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FDA OKs Pfizer NADAs for Canine Vomiting

03/01/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of two Pfizer NADAs that provide for the veterinary prescription use of maropitant citrate tablets and maropitant citrate injectable solution for managing vomiting in dogs. Pfizer also filed NADA 141-263 for Cerenia (maropitant citrate) injectable solution, used by veterinary prescription in dogs for preventing and treating acute vomiting. The application is approved as of 1/29, and 21 CFR part 522 is amended by adding new Sec. 522.1315 to reflect the approval. To view this final rule, click here.

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