Federal Register #FDA-2026-N-0002

FDA Final Rule: Animal Drug Application Approvals, Withdrawals, and Sponsor Changes

This final rule from the Food and Drug Administration (FDA) updates animal drug regulations to reflect recent application actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs). - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors Mentioned: - Intervet, Inc. - Parnell Technologies Pty. Ltd. - Pegasus Laboratories, Inc. - Felix Pharmaceuticals Pvt. Ltd. - Norbrook Laboratories Ltd. - Boehringer Ingelheim Animal Health USA, Inc. - Elanco US Inc. - Zoetis - Cronus Pharma Specialities India Private Ltd. - Baxter Healthcare Corporation - Products/Services Affected: - EXZOLT CATTLECA (fluralaner topical solution) - nixiFLOR (florfenicol and flunixin meglumine injectable solution) - KBROVET (potassium bromide chewable tablets) - Maropitant Citrate Chewable Tablets - Defendazole (fenbendazole) - BRAVECTO PLUS (fluralaner and moxidectin topical solution) - VETMEDIN Solution (pimobendan oral solution) - NEXGARD PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) - Cronoquin Tablets (marbofloxacin tablets) - Sevoflurane - Atipamezole Hydrochloride - Notable Requirements: - The rule includes approvals, withdrawals, and sponsor changes for animal drugs - Technical amendments to improve regulatory accuracy and readability - Updates to labeling for certain drugs - No specific purchase quantities or part numbers are provided

Description

The Food and Drug Administration (FDA) is amending the 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 January, February, and March 2026. The amendments also improve the accuracy and readability of the animal drug regulations. This final rule is effective July 7, 2026, and includes technical amendments and updates to labeling for certain drugs.

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