FDA Updates Pet Meds: Approvals, Withdrawals, Yawns
Published Date: 1/21/2025
Rule
Summary
The FDA updated rules about new animal medicines approved or withdrawn in late 2024, making the info clearer and easier to understand. This affects drug makers, vets, and pet owners by showing which medicines are officially approved or no longer allowed starting January 21, 2025. You can check details online, including safety reviews and patent info, to stay in the know without any surprise costs or delays.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
New approvals expand pet parasite treatments
The FDA amended regulations to reflect approvals and supplemental approvals (October–December 2024) for multiple dog and cat parasite products (examples include NEXGARD PLUS, CREDELIO QUATTRO, SIMPARICA TRIO, REVOLUTION PLUS, BRAVECTO 1-MONTH, and others) that treat or prevent heartworm, fleas, ticks (including Haemaphysalis longicornis, the Asian longhorned tick), and various intestinal parasites for 1 month. The rule lists product-specific age and weight limits (for example, many chewables are for dogs and puppies 8 weeks of age and older and weighing 4.0–4.4 pounds or greater) and is effective January 21, 2025.
Livestock feed additives approved for weight and emissions
The FDA approved or updated approvals (October–December 2024) for several feed/implant products used in beef production (examples: EXPERIOR/lubabegron, melengestrol acetate medicated articles, SYNOVEX implants) that are indicated for increased rate of weight gain, improved feed efficiency, and reduction of ammonia gas emissions in growing beef steers and heifers. These approvals include specific dosing ranges and feeding limitations and are effective January 21, 2025.
Some drugs limited to veterinarian orders
The amended regulations explicitly state limitations for certain products (for example, lotilaner chewables and propofol conditions) that 'Federal law restricts this drug to use by or on the order of a licensed veterinarian.' These restrictions are codified in the updated sections and effective January 21, 2025.
FDA posts animal-drug review documents online
The FDA published that for new animal drug approvals and related actions from October–December 2024 you can obtain environmental reviews under NEPA, FOIA summaries of safety/effectiveness, marketing exclusivity, and patent information online at Animal Drugs @ FDA (https://animaldrugsatfda.fda.gov/adafda/views/#/search). This makes approval and safety documents easier to find starting with the entries listed for those months.
Withdrawal of approvals for two animal drugs
FDA notes withdrawal of approval for NADA 140-810 (DERMA-VET ointment) effective December 23, 2024 because it is no longer manufactured or marketed, and withdrawal of ANADA 200-257 (Ketamine HCL injection) effective June 29, 2023 for the same reason. These products are no longer approved as of those dates.
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