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Tuesday, May 14, 2024

 

  • Today, the FDA announced that is has finalized Guidance for Industry (GFI) #120:  Veterinary Feed Directive Regulation Questions and Answers, to provide guidance to industry on the requirements of the veterinary feed regulations   (i.e., the Veterinary Feed Directive (VFD) final rule). The VFD final rule outlines the process for authorizing the use of approved animal drugs intended for use in or on the feed of food-producing animals that require veterinary oversight, including medically important antimicrobials when needed for specific animal health purposes. This final guidance also serves as a Small Entity Compliance Guide.

  • On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs. Pimomedin (pimobendan) chewable tablets is approved for the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). Pimomedin is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. Pimomedin is only available by prescription from a licensed veterinarian.

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