Animal Drugs

animal-drugs
TitlePublishedFR Doc.Description
TitlePublishedFR Doc.Description
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address2018-Apr-052018-06961The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and a change of a sponsor's name and address.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address2018-Mar-302018-06358The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.
Health and Human Services Department -- Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements2018-Feb-142018-02757The Food and Drug Administration (FDA, Agency, or we) is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted to FDA in an electronic format that we can process, review, and archive. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.
Health and Human Services Department -- New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator2017-Dec-282017-27973The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under this final rule, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This final rule will help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications2017-Dec-132017-26753The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address2017-Sep-182017-19602The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address and to make technical amendments to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship2017-May-102017-09364The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name2017-Mar-012017-03930The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the change of sponsorship of an application and a change of a sponsor's name.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address2017-Feb-242017-03677The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor's address.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications2017-Feb-242017-03596The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications2016-Dec-272016-31084The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications2016-Dec-272016-31083The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.
Health and Human Services Department -- New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food2016-Oct-282016-26043The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled ``New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.'' The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address2016-Sep-302016-23230The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine2016-Sep-142016-21985The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2- way, fixed-ratio, combination drug product without penicillin.
Health and Human Services Department -- Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs2016-Aug-312016-20471The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address2016-Aug-292016-19914The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications, changes of sponsors' names and addresses, and the voluntary withdrawals of approval of applications.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Category Definitions2016-Aug-242016-20149The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
Health and Human Services Department -- Disqualification of a Clinical Investigator2016-Aug-242016-19876The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feed; Category Definitions2016-Aug-242016-20148The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
Health and Human Services Department -- New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction2016-Aug-112016-18809The Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor2016-Jul-262016-17501The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship2016-Jun-082016-13517The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.
Health and Human Services Department -- Antimicrobial Animal Drug Sales and Distribution Reporting2016-May-112016-11082The Food and Drug Administration (FDA or we) is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to us on the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This final rule codifies the reporting requirements established in section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA). The final rule also includes an additional reporting provision intended to enhance our understanding of antimicrobial new animal drug sales intended for use in specific food- producing animal species and the relationship between such sales and antimicrobial resistance.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Correction2016-Apr-282016-09865The Food and Drug Administration (FDA) published a document in the Federal Register of April 18, 2016 (81 FR 22520), amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. That rule included two amendatory instructions that cited incorrect sections of 21 CFR part 524.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship2016-Apr-182016-08827The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in January and February.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship2016-Mar-302016-07135The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in November and December 2015.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and Redundant Regulations2016-Mar-072016-04945The Food and Drug Administration (FDA) is removing regulations that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete. FDA has other strategies for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern, and the only remaining animal drug use listed in these regulations is now listed elsewhere in the new animal drug regulations.
Health and Human Services Department -- Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib2016-Jan-212016-01100The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate2015-Dec-222015-32000The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship2015-Dec-092015-31042The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in September and October 2015.
Health and Human Services Department -- New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct2015-Nov-242015-29902The Food and Drug Administration (FDA, the Agency) is amending the animal drug regulations to reflect the approval of a new animal drug application (NADA) filed by AquaBounty Technologies, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) gene construct in a lineage of genetically engineered Atlantic salmon.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address2015-Oct-132015-25918The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsor, a change of sponsor's address, a revised food safety warning, the voluntary withdrawal of approval of an NADA, and a technical amendment. This technical amendment is being made to improve the accuracy of the regulations.
Health and Human Services Department -- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals2015-Sep-172015-21921The Food and Drug Administration (FDA or we) is adding regulations for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. These regulations will, for the first time, establish requirements for the current good manufacturing practice (CGMP) for food for animals. In addition, we are adding requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals and to implement new statutory provisions in the FDA Food Safety Modernization Act (FSMA). The rule is intended to build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications2015-Sep-042015-21905The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a nonsubstantive change. This technical amendment is being made to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor2015-Jun-162015-14734The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several nonsubstantive changes. These technical amendments are being made to improve the accuracy of the regulations.
Health and Human Services Department -- Veterinary Feed Directive2015-Jun-032015-13393The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA's VFD program while protecting human and animal health.
Health and Human Services Department -- Antimicrobial Animal Drug Sales and Distribution Reporting2015-May-202015-12081The Animal Drug User Fee Amendments of 2008 (ADUFA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, and further requires FDA to publish annual summary reports of the data it receives from sponsors. At this time, FDA is issuing proposed regulations for the administrative practices and procedures for animal drug sponsors who must report under this law. This proposal also includes an additional reporting provision intended to enhance FDA's understanding of antimicrobial animal drug sales intended for use in specific food- producing animal species.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address2015-Apr-082015-08025The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several non-substantive changes. These technical amendments are being made to improve the accuracy of the regulations.
Health and Human Services Department -- Food and Drug Administration Regulations; Change of Addresses; Technical Amendment2015-Apr-032015-07268The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are being made to ensure the accuracy of the Agency's regulations.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor2015-Mar-132015-05644The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code.
Health and Human Services Department -- New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications2014-Dec-152014-29249The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.
Health and Human Services Department -- Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment2014-Nov-142014-26914The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Health and Human Services Department -- New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor2014-Oct-282014-25588The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during August 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of two NADAs and one ANADA, and to reflect a revised food safety warning.
Health and Human Services Department -- New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin2014-Sep-082014-20325The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to add a cross reference to a tolerance.
Health and Human Services Department -- New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin2014-Jul-312014-17912The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove a cross-reference to a combination drug medicated feed that is no longer codified.
Health and Human Services Department -- New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address2014-Jul-022014-15276The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April and May 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove an obsolete entry for a drug for which approval was withdrawn in 1996.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline; Procaine Penicillin; and Sulfamethazine2014-Jul-022014-15274The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for growth promotion indications in swine and to reflect the reformulation of the Type A medicated article as a two-way, fixed-ratio, combination drug product without penicillin.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Change of Sponsor2014-May-202014-10415The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.
Health and Human Services Department -- New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine2014-Apr-152014-08445The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin2014-Apr-102014-08011The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin; Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone; Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor2014-Apr-012014-07220The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect previous approval of revised food safety warnings. This is being done to improve the accuracy of the regulations. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address.
Health and Human Services Department -- Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction2014-Mar-312014-06994The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect the withdrawal of approval of new animal drug applications (NADAs) that appeared in the Federal Register of February 27, 2014 (79 FR 10976). That document listed an NADA for which a withdrawal of approval (WOA) was not intended and failed to remove all conditions of use associated with the withdrawn NADAs. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor2014-Mar-252014-06131The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 104 approved new animal drug applications (NADAs) and 5 approved abbreviated new animal drug applications (ANADAs) for implantation or injectable dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.
Health and Human Services Department -- Zoetis Inc., Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin2014-Mar-202014-05882The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) for three-way, fixed-ratio combination drug Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File2014-Mar-172014-05430The Food and Drug Administration (FDA) is amending its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information will be disclosed by the Agency. This change will ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It will also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
Health and Human Services Department -- New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File2014-Mar-172014-05432The Food and Drug Administration (FDA or Agency) is proposing to amend its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information would be disclosed by the Agency. This change would ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It would also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
Health and Human Services Department -- Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug2014-Feb-272014-02617The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 69 new animal drug applications (NADAs) and 22 abbreviated new animal drug applications (ANADAs) for use of arsanilic acid, carbarsone, or roxarsone Type A medicated articles to manufacture combination drug Type B and Type C medicated feeds. This action is being taken at the sponsor's request because the products are no longer manufactured or marketed. FDA is also amending the animal drug regulations to remove entries describing conditions of use for combination drug medicated feeds for which no NADA is approved. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor2014-Feb-272014-01958The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 54 approved new animal drug applications (NADAs) and 1 approved abbreviated new animal drug application (ANADA) for topical, intramammary, and certain other dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc.
Health and Human Services Department -- New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address2014-Feb-272014-01959The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address.
Health and Human Services Department -- Current Good Manufacturing Practice for Medicated Feeds2014-Jan-232014-01299The Food and Drug Administration (FDA) is amending the regulations for good manufacturing practice of animal feeds containing a new animal drug to correctly cite the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate2014-Jan-162014-00721The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of two new animal drug applications (NADAs) held by Argent Laboratories. Withdrawal of approval of these NADAs was at the sponsor's request because the products are no longer manufactured or marketed.
Health and Human Services Department -- Withdrawal of Approval of New Animal Drug Applications; Roxarsone2013-Dec-272013-30838The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Bambermycins2013-Dec-162013-29810The Food and Drug Administration (FDA) is amending the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for which free-choice, loose-mineral medicated feeds containing bambermycins are approved. This action is being taken because a level of selenium for inclusion in such feeds has not been established for dairy cattle under the food additive regulation for selenium.
Health and Human Services Department -- Veterinary Feed Directive2013-Dec-122013-29696The Food and Drug Administration (FDA) is proposing to amend its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This proposed amendment is intended to improve the efficiency of FDA's VFD program.
Health and Human Services Department -- New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of Sponsor2013-Dec-092013-29234The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of an ANADA.
Health and Human Services Department -- Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid2013-Nov-262013-28256The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the sponsor's request because the product is no longer manufactured or marketed.
Health and Human Services Department -- Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone2013-Nov-222013-27917The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of three new animal drug applications (NADAs) for roxarsone or carbarsone Type A medicated articles at the sponsor's request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin2013-Nov-052013-26473The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2013. FDA is also informing the public of the availability of summaries on the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
Health and Human Services Department -- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals2013-Oct-292013-25126The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals. FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin2013-Oct-252013-25172The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Amprolium; Meloxicam2013-Sep-172013-22523The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during August 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol2013-Aug-272013-20538The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin2013-Aug-232013-20616The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs), held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin2013-Aug-232013-20540The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection2013-Jul-242013-17754The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to Sogeval S.A., and a change of sponsor for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly & Co.
Health and Human Services Department -- Animal Feeds Contaminated With Salmonella Microorganisms2013-Jul-162013-16971The Food and Drug Administration (FDA or Agency) is revoking an advisory opinion on animal feeds contaminated with Salmonella microorganisms. This action is being taken because that advisory opinion is being superseded by the current FDA enforcement strategy articulated in a final compliance policy guide (CPG) on Salmonella in food for animals.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol2013-Jul-152013-16258The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction2013-Jun-052013-13331The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the Federal Register of April 30, 2013. FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Clindamycin; Enrofloxacin2013-May-222013-12134The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2013. FDA is also informing the public of the availability of summaries for the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor2013-May-132013-11283The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name and address from Purina Mills, Inc., to Purina Nutrition LLC, and a change of sponsor for a new animal drug application (NADA) from Land O'Lakes Purina Feed LLC to Purina Nutrition LLC. The regulations are also being amended to reflect that Zoetis Inc. is a sponsor of approved NADAs.
Health and Human Services Department -- New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin2013-Apr-302013-10152The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor2013-Apr-092013-07542The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.
Health and Human Services Department -- New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin2013-Apr-032013-07571The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during February 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide2013-Mar-252013-06748The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship for an NADA and ANADA, and a change of a sponsor's drug labeler code.
Health and Human Services Department -- New Animal Drugs; Changes of Sponsor2013-Mar-222013-06126The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC.
Health and Human Services Department -- New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N2013-Mar-072013-04999The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of 19 new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA). The applications are being withdrawn for lack of compliance with the reporting requirements in an FDA regulation.
Health and Human Services Department -- New Animal Drugs; Cefpodoxime; Meloxicam2013-Jan-282013-01647The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Meloxicam; Nicarbazin2013-Jan-022012-31234The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food2012-Dec-052012-29322The Food and Drug Administration (FDA) is proposing to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. In addition, we are proposing to add definitions for key terms. The purpose of the revision is to enhance understanding of tolerance determination and improve the readability of the regulations.
Health and Human Services Department -- New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin2012-Oct-232012-25989The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Address; Monensin; Spinosad; Tilmicosin2012-Oct-042012-24475The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin2012-Oct-032012-24331The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin2012-Sep-192012-23065The Food and Drug Administration (FDA) is amending the animal drug regulations to remove a warning for growing cattle on pasture or in dry lot and to codify all monensin free-choice Type C medicated feeds in 21 CFR part 558. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin2012-Sep-142012-22646The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
Health and Human Services Department -- New Animal Drugs; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin2012-Sep-102012-22196The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
Health and Human Services Department -- New Animal Drugs; Enrofloxacin; Tylvalosin2012-Sep-102012-22194The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals2012-Aug-222012-20609The Food and Drug Administration (FDA) is amending its regulations regarding compounds of carcinogenic concern used in food- producing animals. Specifically, the Agency is clarifying the definition of ``S<INF>o</INF>'' and revising the definition of ``S<INF>m</INF>'' so that it conforms to the clarified definition of S<INF>o</INF>. Other clarifying and conforming changes are also being made.
Health and Human Services Department -- New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel2012-Aug-092012-19498The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension2012-Aug-062012-19147The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin2012-Jul-032012-16203The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- Conditionally Approved New Animal Drugs for Minor Use and Minor Species; Masitinib2012-Jun-152012-14635The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a conditionally approved supplemental application for conditional approval of a new animal drug (CNADA) intended for a minor use filed by AB Science. The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name2012-Jun-042012-13409The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Novopharm Ltd. to Teva Canada Ltd.
Health and Human Services Department -- New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol2012-May-312012-13095The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol; Melengestrol; Ractopamine; Zilpaterol2012-May-302012-13010The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
Health and Human Services Department -- New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin2012-May-172012-11937The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Change of Sponsor; Griseofulvin Powder; Levamisole Hydrochloride Powder; Oxytetracycline Powder2012-May-142012-11382The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five abbreviated new animal drug applications (ANADAs) for griseofulvin powder, levamisole hydrochloride soluble powder, and oxytetracycline hydrochloride soluble powder from Teva Animal Health, Inc., to Cross Vetpharm Group, Ltd.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Change of Sponsor Name and Address; Fomepizole2012-May-072012-10892The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor name from Bioniche Teoranta to Mylan Institutional, LLC; a change of sponsor for fomepizole injectable solution from Synerx Pharma, LLC, to Mylan Institutional, LLC; and a change of sponsor address for Modern Veterinary Therapeutics, LLC.
Health and Human Services Department -- New Animal Drugs; Ceftiofur Crystalline Free Acid; Gamithromycin; Tylosin2012-May-032012-10632The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during February 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Health and Human Services Department -- Disqualification of a Clinical Investigator2012-Apr-302012-10292The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Tiamulin2012-Apr-232012-9708The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for approval of a new concentration of a Type A medicated article.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Tiamulin2012-Apr-172012-9196The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to the production indications for use of increased rate of weight gain and improved feed efficiency in swine.
Health and Human Services Department -- Veterinary Feed Directive; Draft Text for Proposed Regulation2012-Apr-132012-8844The Food and Drug Administration (FDA) is announcing the availability of draft text for a proposed regulation intended to improve the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text for a proposal available because of the complex scientific and regulatory issues involved, and because of the potential impact that changes to the VFD regulations may have on stakeholders. The Agency invites the public to submit comments with questions and concerns about the draft text for a proposed regulation.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Change of Sponsor; Lincomycin Hydrochloride Soluble Powder; Penicillin G Potassium in Drinking Water; Tetracycline Powder2012-Apr-092012-8322The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) for lincomycin hydrochloride; penicillin G potassium, USP; and tetracycline hydrochloride soluble powders administered in drinking water from Teva Animal Health, Inc., to Quo Vademus, LLC.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Pergolide2012-Mar-192012-6544The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of pergolide mesylate tablets in horses for the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease).
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Phenylpropanolamine2012-Mar-192012-6553The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Pegasus Laboratories, Inc. The NADA provides for the veterinary prescription use of phenylpropanolamine hydrochloride chewable tablets for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; N-Methyl-2-Pyrrolidone; Correction2012-Feb-172012-3747The Food and Drug Administration (FDA) published a document in the Federal Register of November 25, 2011 (76 FR 72617), codifying a method of detection for residues of n-methyl-2-pyrrolidone in edible tissues of cattle. That document contained a universal resource locator (URL) linking to the Agency's Web site that did not reflect the most recent URL.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Chlortetracycline Powder2012-Feb-062012-2633The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an abbreviated new animal drug application (ANADA) for chlortetracycline soluble powder from Teva Animal Health, Inc., to Quo Vademus, LLC.
Health and Human Services Department -- New Animal Drugs; Chloramphenicol, Diethylcarbamazine Citrate, Hygromycin B, Methoxyflurane, Neomycin Sulfate, Penicillin G, Phenylbutazone, Pyrantel Tartrate, Tylosin Phosphate, and Sulfamethazine2012-Feb-012012-2103The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 20 new animal drug applications (NADAs).
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin2012-Jan-272012-1743The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for an additional dosage regimen for use of danofloxacin mesylate injectable solution for the treatment of bovine respiratory disease in beef cattle.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin2012-Jan-272012-1755The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for approval of free-choice feeds for growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers).
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Milbemycin Oxime, Lufenuron, and Praziquantel2012-Jan-272012-1744The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of milbemycin oxime, lufenuron, and praziquantel for the prevention of heartworm disease, for prevention and control of fleas, and for the treatment and control of various internal parasites in dogs.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Gentamicin Sulfate2012-Jan-272012-1753The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The ANADA provides for use of gentamicin sulfate soluble powder used to make medicated drinking water for swine.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name2012-Jan-272012-1756The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Nycomed US, Inc., to Fougera Pharmaceuticals, Inc.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor Analog-Diphtheria Toxoid Conjugate2012-Jan-272012-1754The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA extends the slaughter interval for intact male swine injected with gonadotropin releasing factor analog-diphtheria toxoid conjugate injectable solution.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Deracoxib2012-Jan-262012-1622The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health U.S., Inc. The supplemental NADA provides for veterinary prescription use of deracoxib tablets in dogs for the control of postoperative pain and inflammation associated with dental surgery and the addition of a 12-milligram (mg) size tablet.
Health and Human Services Department -- Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray2012-Jan-252012-1501The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for the veterinary prescription use of gentamicin sulfate and betamethasone valerate topical spray in dogs.
Health and Human Services Department -- Import Tolerances for Residues of Unapproved New Animal Drugs in Food2012-Jan-252012-1430The Food and Drug Administration (FDA) is proposing to establish procedures by which a person may request that the Agency establish or amend tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances), as well as procedures to revoke an existing import tolerance. Such import tolerances provide a basis for legally marketing food of animal origin that is imported into the United States and contains residues of unapproved new animal drugs.
Health and Human Services Department -- New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition2012-Jan-062012-35The Food and Drug Administration (FDA, the Agency) is issuing an order prohibiting certain extralabel uses of cephalosporin antimicrobial drugs in certain food-producing animals. We are issuing this order based on evidence that certain extralabel uses of these drugs in these animals will likely cause an adverse event in humans and, therefore, present a risk to the public health.
Health and Human Services Department -- Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution2011-Dec-292011-33382The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Monensin2011-Dec-212011-32427The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA revises a manufacturing specification for monensin free-choice Type C medicated feed for growing cattle on pasture or in dry lot.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Zinc Gluconate2011-Dec-212011-32591The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for zinc gluconate injectable solution from Technology Transfer, Inc., to Ark Sciences, Inc.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Cyclosporine2011-Dec-202011-32526The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of cyclosporine oral solution, USP (MODIFIED) for the control of feline allergic dermatitis.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Estriol2011-Dec-162011-32214The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of estriol tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Tilmicosin2011-Dec-092011-31613The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, a division of Eli Lilly & Co. The supplemental NADA provides for use of tilmicosin Type C medicated feeds by veterinary feed directive for the control of bovine respiratory disease in groups of beef and nonlactating dairy cattle.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Eprinomectin; N-Methyl-2-Pyrrolidone2011-Nov-252011-30329The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial Ltd. The NADA provides for the veterinary prescription use of eprinomectin by injection for the treatment and control of internal and external parasites of cattle on pasture with persistent effectiveness. The current tolerance for the marker residue for total residues of eprinomectin in edible tissues of cattle is being lowered. The method of detection for residues of the carcinogenic excipient n-methyl-2- pyrrolidone (NMP) in edible tissues of cattle is also being codified.
Health and Human Services Department -- Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin2011-Nov-252011-30328The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for addition of a warning statement against the use of eprinomectin topical solution in preruminating calves intended for veal.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin2011-Oct-202011-27139The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for use of increased dose levels of monensin in three-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter containing melengestrol acetate, monensin, and tylosin.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin2011-Sep-302011-25220The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for use of increased dose levels of melengestrol acetate and monensin in two-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Tylosin2011-Sep-232011-24461The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The ANADA provides for use of tylosin tartrate soluble powder in chickens, turkeys, swine, and honey bees.
Health and Human Services Department -- Tolerances for Residues of New Animal Drugs in Food; Progesterone2011-Sep-192011-23867The Food and Drug Administration (FDA) is amending the animal drug regulations to update the allowable incremental increase for residues of progesterone in edible tissues of cattle and sheep based on the 1994 revised daily consumption values. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs; Gamithromycin2011-Sep-192011-23874The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for the veterinary prescription use of gamithromycin injectable solution for the management of bovine respiratory disease (BRD). FDA is also amending the regulations to add the established tolerances for residues of gamithromycin in edible tissues of cattle.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin2011-Sep-192011-23865The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of an ivermectin injectable solution for treatment and control of various internal and external parasites in cattle, swine, reindeer, and American bison.
Health and Human Services Department -- New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene Disalicylate, Flunixin, Gonadotropin Releasing Factor Analog-Diphtheria Toxoid Conjugate, Methylprednisolone, and Sulfamethazine2011-Aug-252011-21721The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect revised human food safety warnings on dosage form new animal drug product labeling that have not been codified. The regulations are also being amended to correct the wording of certain other conditions of use, to correct minor errors, and to revise some sections to reflect a current format. These actions are being taken to comply with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to improve the accuracy and readability of the regulations.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Change of Sponsor; Chlortetracycline; Sulfamethazine2011-Aug-112011-20404The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five new animal drug applications (NADAs) from Fort Dodge Animal Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Moxidectin2011-Aug-092011-20182The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three approved new animal drug applications (NADAs) for dosage form products containing moxidectin from Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Amprolium2011-Jul-122011-17465The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The original ANADA provides for the use of amprolium soluble powder for the treatment of coccidiosis in chickens and turkeys.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name and Address2011-Jul-112011-17292The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Alpharma, LLC, to Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc. The sponsor's mailing address will also be changed.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Change of Sponsor2011-Jul-082011-17151The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Address2011-Jul-062011-16845The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of address for Huvepharma AD, a sponsor of approved new animal drug applications.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Amprolium2011-Jul-012011-16501The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the use of amprolium soluble powder as an aid in the treatment and prevention of coccidiosis in calves.
Health and Human Services Department -- Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments2011-Jun-012011-13488The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Reading room's fax and room number. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor-Diphtheria Toxoid Conjugate2011-May-132011-11762The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of gonadotropin releasing factor-diphtheria toxoid conjugate by subcutaneous injection for temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin2011-Apr-222011-9765The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA provides for the addition of a pathogen to the indications for use of enrofloxacin solution in cattle, as a single injection, for the treatment of respiratory disease.
Health and Human Services Department -- Disqualification of a Clinical Investigator2011-Apr-132011-8786The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. This proposal is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Robenacoxib2011-Apr-052011-8053The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of robenacoxib tablets in cats for the control of postoperative pain and inflammation.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine2011-Mar-312011-7560The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 13 new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- New Animal Drugs; Oxytetracycline2011-Mar-282011-7216The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Pennfield Oil Co. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder for control of American and European foulbrood in honey bees and for skeletal marking of finfish fry and fingerlings.
Health and Human Services Department -- New Animal Drugs; Arsanilate Sodium; Sulfaethoxypyridazine2011-Mar-282011-7214The Food and Drug Administration (FDA) is amending the animal drug regulations to remove sections pertaining to use of arsanilate sodium and sulfaethoxypyridazine in medicated feed because there are no currently approved new animal drug applications (NADAs) for such uses. Conforming amendments are also being made. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction2011-Mar-242011-6789The Food and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained an incorrect table entry describing the maximum florfenicol concentration in Type B medicated swine feeds. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran; Roxarsone; Correction2011-Mar-242011-6790The Food and Drug Administration (FDA) published a document in the Federal Register of October 26, 2010 (75 FR 65565) amending the animal drug regulations. The October 26, 2010, final rule amended the regulations by removing those portions that reflect approval of eight new animal drug applications. The final rule inadvertently failed to add conforming amendments in Sec. 558.530. FDA is correcting the animal drug regulations by removing cross references for use of the withdrawn drugs in combination drug medicated feed. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name and Address; Corrections2011-Mar-242011-6795The Food and Drug Administration (FDA) published a document in the Federal Register of April 20, 2010 (75 FR 20522) amending the animal drug regulations to reflect changes to a sponsor's name and address. That document contained errors in the regulatory text. FDA is correcting the tables listing sponsors of approved animal drug applications (NADAs) by adding a change to the sponsor's drug labeler code (DLC). Cross-references to the sponsor's DLC are amended in two sections of the Code of Federal Regulations (CFR) containing the conditions of use approved animal drug products. These corrections are being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- Certain Other Dosage Form New Animal Drugs; Detomidine; Correction2011-Mar-242011-6791The Food and Drug Administration (FDA) published a document in the Federal Register of April 23, 2010 (75 FR 21162), that amended the animal drug regulations to reflect approval of an original new animal drug application (NADA). FDA is correcting a paragraph describing limitations to the approved conditions of use for detomidine hydrochloride oromucosal gel in horses. This correction is being made to improve the accuracy of the animal drug regulations.
Health and Human Services Department -- Tolerances for Residues of New Animal Drugs in Food; 2-Acetylamino-5-Nitrothiazole; Buquinolate; Chlorobutanol; Estradiol and Related Esters; Ethylenediamine; Florfenicol; Flunixin; Furazolidone; Hydrocortisone; Methylparaben; Methylprednisolone; Prednisolone; Prednisone; Progesterone; Propylparaben; and Salicylic Acid2011-Mar-232011-6796The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the revocation of tolerances for residues of various substances in food because approval has been withdrawn for the underlying food additive petitions (FAPs) or new animal drug applications (NADAs). This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime2011-Mar-082011-5144The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary prescription use of chewable tablets containing spinosad and milbemycin oxime in dogs for the treatment and prevention of flea infestations and for the prevention and control of various internal parasites.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin2011-Mar-022011-4546The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- New Animal Drugs; Masitinib2011-Feb-042011-2519The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect conditional approval of an application for a new animal drug intended for a minor use filed by AB Science. The application for conditional approval provides for the veterinary prescription use of masitinib mesylate tablets in dogs.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin2011-Jan-202011-1040The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The NADA provides for veterinary prescription use of a combination drug injectable solution containing oxytetracycline and flunixin meglumine in cattle.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone2011-Jan-182011-909The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for follicle stimulating hormone from Ausa International, Inc., to Therio, Inc.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor2011-Jan-182011-904The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for hemoglobin glutamer-200 from Biopure Corp. to OPK Biotech, LLC.
Health and Human Services Department -- New Animal Drugs; Deslorelin2010-Dec-282010-32554The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Thorn Bioscience LLC. The NADA provides for the use of deslorelin acetate injectable suspension in mares for inducing ovulation.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Address2010-Dec-212010-31952The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of address for Intervet, Inc., a sponsor of approved new animal drug applications.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals2010-Dec-202010-31887The Food and Drug Administration (FDA) is proposing to amend its regulations regarding compounds of carcinogenic concern used in food-producing animals. Specifically, the Agency is clarifying the definition of ``S<INF>o</INF>'' and revising the definition of ``S<INF>m</INF>'' so that it conforms to the clarified definition of S<INF>o</INF>. Other clarifying and conforming changes are also being made.
Health and Human Services Department -- New Animal Drugs; Mupirocin2010-Dec-202010-31870The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Taro Pharmaceuticals U.S.A., Inc. The ANADA provides for veterinary prescription use of mupirocin ointment for the treatment of bacterial skin infections in dogs.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Flunixin2010-Dec-082010-30769The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Agri Laboratories, Ltd. The supplemental ANADA provides for use of flunixin meglumine solution by intravenous injection in lactating dairy cows for control of pyrexia associated with acute bovine mastitis.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Tylosin2010-Dec-082010-30814The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Huvepharma AD. The ANADA provides for use of tylosin tartrate soluble powder in drinking water of chickens, turkeys, swine, and honey bees for the treatment or control of various bacterial diseases.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name and Address2010-Nov-262010-29693The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Belcher Pharmaceuticals, Inc., to Belcher Pharmaceuticals, LLC. The sponsor's mailing address will also be changed.
Health and Human Services Department -- Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine2010-Nov-222010-29326The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplementary new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplement provides for minor revisions to labeling.
Health and Human Services Department -- New Animal Drugs for Minor Use and Minor Species2010-Nov-152010-28551The Food and Drug Administration (FDA) is proposing to amend its regulations regarding new animal drugs for minor use and minor species to update language and to clarify the regulations consistent with the explanations in the preambles to the proposed and final rules establishing them. This action is being taken to ensure accuracy and clarity in the Agency's regulations. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Health and Human Services Department -- New Animal Drugs for Minor Use and Minor Species2010-Nov-152010-28550The Food and Drug Administration (FDA) is amending its regulations regarding new animal drugs for minor use and minor species to update language and to clarify the regulations consistent with the explanations in the preambles to the proposed and final rules establishing them. This action is being taken to ensure accuracy and clarity in the Agency's regulations. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the Agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Sulfadiazine and Pyrimethamine Suspension2010-Nov-152010-28549The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for sulfadiazine and pyrimethamine oral suspension from Animal Health Pharmaceuticals, LLC, to Pegasus Laboratories, Inc.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name2010-Nov-102010-28307The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from North American Nutrition Companies, Inc., to Provimi North America, Inc.
Health and Human Services Department -- Oral Dosage Form New Animal Drugs; Domperidone2010-Nov-012010-27524The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Dechra, Ltd. The NADA provides for the veterinary prescription use of domperidone oral gel for prevention of fescue toxicosis in periparturient mares.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor; Monensin Blocks2010-Oct-282010-27287The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor from Farmland Industries, Inc., to Land O' Lakes Purina Feed LLC for a free-choice supplement block containing monensin for pasture cattle.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran2010-Oct-262010-27011The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- Certain Other Dosage Form New Animal Drugs; Progesterone Intravaginal Inserts2010-Oct-142010-25893The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of progesterone intravaginal inserts and dinoprost tromethamine by injection for synchronization of estrus in lactating dairy cows.
Health and Human Services Department -- Implantation and Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid2010-Oct-122010-25527The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for veterinary prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the control of swine respiratory disease (SRD) in groups of pigs where SRD has been diagnosed.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Melengestrol2010-Sep-302010-24480The Food and Drug Administration (FDA) is amending the animal drug regulations to more accurately reflect the recent approval of two supplemental new animal drug applications (NADAs) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADAs provided for increased levels of monensin in two-way Type C medicated feeds containing melengestrol acetate and monensin, and in three-way Type C medicated feeds containing melengestrol acetate, monensin, and tylosin phosphate for heifers fed in confinement for slaughter. These amendments are being made to improve the accuracy of the regulations.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine2010-Sep-302010-24494The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a preanesthetic to general anesthesia in cats.
Health and Human Services Department -- Implantation and Injectable Dosage Form New Animal Drugs; Firocoxib2010-Sep-282010-24254The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial Ltd. The NADA provides for the veterinary prescription use of firocoxib injectable solution in horses for the control of pain and inflammation associated with osteoarthritis.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol; Lincomycin; Pyrantel Tartrate; and Tylosin Phosphate and Sulfamethazine2010-Sep-142010-22808The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of four new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Propofol2010-Jul-062010-16301The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for veterinary prescription use of propofol as an anesthetic in dogs and cats.
Health and Human Services Department -- New Animal Drugs for Use in Animal Feeds; Florfenicol2010-Jun-172010-14611The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for the manufacture of florfenicol Type B medicated swine feeds.
Health and Human Services Department -- Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos2010-May-052010-10564The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol2010-Apr-292010-9871The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for use of an injectable solution of butorphanol tartrate in cats for the relief of pain.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name and Address2010-Apr-202010-9057The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor's mailing address will be changed.
Health and Human Services Department -- New Animal Drugs; Change of Sponsor's Name and Address2010-Apr-202010-9045The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Minrad, Inc. to Piramal Critical Care, Inc. The sponsor's mailing address will also be changed.
Health and Human Services Department -- Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Propofol2010-Apr-192010-8945The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Intervet, Inc., to Teva Animal Health, Inc.
Health and Human Services Department -- Ophthalmic and Topical Dosage Form New Animal Drugs; Orbifloxacin, Mometasone Furoate Monohydrate, and Posaconazole Suspension2010-Apr-012010-7163The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of a suspension containing orbifloxacin, mometasone furoate monohydrate, and posaconazole for the treatment of otitis externa in dogs.
Health and Human Services Department -- New Animal Drugs; Removal of Obsolete and Redundant Regulations2010-Mar-312010-7108The Food and Drug Administration (FDA) is removing portions of a regulation that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete or redundant. The portions of the regulation being removed are provisions listing certain feed use combinations for oxytetracycline and neomycin in the tables contained in that regulation. This rule does not finalize the provisions of the proposed rule regarding removing the remainder of the regulation.
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