Federal Register #FDA2025N0002

FDA Final Rule Updates Animal Drug Regulations for Approvals, Withdrawals, and Sponsor Changes

This final rule from the Food and Drug Administration (FDA) updates animal drug regulations to reflect recent application actions and technical amendments: - Government Buyer - Department of Health and Human Services, Food and Drug Administration (FDA), Center for Veterinary Medicine - OEMs and Vendors Mentioned - Ivaoes Animal Health - Kinetic Technologies, LLC - Qbiotics Group Ltd. - TriviumVet - Agri Laboratories, Ltd. - Elanco US Inc. - Felix Pharmaceuticals - Pharmgate Inc. - Dechra Veterinary Products - Boehringer Ingelheim - Products and Applications Referenced - CREDELIO QUATTRO (lotilaner, moxidectin, praziquantel, pyrantel chewable tablets) – Part No. 141581 - Clomipramine Hydrochloride Tablets – Part No. 200825 - PENNITRACIN MD 50G (bacitracin methylenedisalicylate Type A medicated article) and MONTEBAN (narasin Type A medicated article) – Part No. 141574 - CREDELIO (lotilaner) – Part No. 141494 - Maropitant Citrate injectable solution – Part No. 200710 - CREDELIO QUATTRO CA1 – Part No. 141619 - LAVERDIA (verdinexor tablets) – Part No. 141614 - COSACTHEN (cosyntropin injection) – Part No. 141576 - VETMEDIN (pimobendan) – Part No. 141273 - Zygolide (pergolide tablets) – Part No. 141489 - Praziquantel Tablets – Part No. 200823 - Klentz (florfenicol, terbinafine, mometasone furoate) otic solution – Part No. 200832 - Robenacoxib (robenacoxib) – Part No. 200829 - Unique or Notable Requirements - Updates include approvals, withdrawals, sponsor changes, and technical amendments for regulatory clarity - Classification of a transcutaneous electrical nerve stimulator for congestion relief as a class II medical device - No procurement or solicitation for products or services is included in this notice - Key Locations - FDA Center for Veterinary Medicine, College Park, MD - FDA Center for Devices and Radiological Health, Silver Spring, MD - National Archives and Records Administration (NARA) - Commissions Public Reference Room, Washington, DC

Description

This final rule by the Food and Drug Administration (FDA) amends animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during October, November, and December 2025. The amendments include approvals, withdrawals, changes of sponsor and sponsor addresses, and technical amendments to improve accuracy and readability of the regulations. The rule is effective April 16, 2026, and aims to update and clarify regulatory information related to animal drugs.

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