Recent Animal Drug Approvals and Safety-Related Labeling Changes

U.S. Food and Drug Administration sent this bulletin at 03/03/2025 09:04 AM EST

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US Food and Drug Administration

Recent Animal Drug Approvals and Safety-Related Labeling Changes

The FDA’s Center for Veterinary Medicine has updated its Recent Animal Drug Approvals page to reflect the February approval of Abbreviated New Animal Drug Application 200-742.

Recent Animal Drug Approvals

The FDA’s Center for Veterinary Medicine has also updated its Recent Animal Drug Safety-Related Labeling Changes page to reflect safety-related labeling changes for the following approved animal drugs:

  • Stelfonta (tigilanol tiglate injection), for dogs, NADA 141-541, January 13, 2025

  • Credelio Cat (lotilaner), NADA 141-528, January 13, 2025

  • Galliprant (grapiprant tablets), for dogs, NADA 141-455, December 3, 2024

  • BRAVECTO 1-MONTH (fluralaner) Chews for Dogs, NADA 141-532, November 25, 2024

  • Synotic (fluocinolone acetonide 0.01% and dimethyl sulfoxide 60%), NADA 045-512, November 25, 2024

Animal Drug Safety-Related Labeling Changes


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