US FDA approves first generic maropitant citrate tablets for use in dogs to prevent vomiting

The US Food and Drug Administration approved maropitant citrate tablets for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs. Maropitant citrate is an antiemetic drug that contains the same active ingredient (maropitant citrate) in the same concentration and dosage form as the approved brand name drug product, Cerenia tablets, which was first approved on January 29, 2007. In addition, the FDA determined that maropitant citrate tablets contain no inactive ingredients that may significantly affect the bioavailability of the active ingredient. Maropitant citrate is only available by prescription from a licensed veterinarian because professional veterinary expertise is needed to determine whether maropitant citrate is an appropriate treatment. The product labelling warns that people handling, administering, or exposed to maropitant citrate may have allergic skin reactions if they get the product on their skin. People administering the product should wash their hands with soap and water after administering the drug. maropitant citrate may also cause eye irritation if the product gets in the eye. In the case of accidental eye exposure, people should flush their eyes with water for 15 minutes and seek medical attention. Maropitant citrate is supplied in 16, 24, 60, or 160 mg of maropitant as maropitant citrate per tablet. Each tablet strength is scored and packaged in blister packs containing four tablets per perforated sheet. Maropitant citrate is sponsored by ZyVet Animal Health Inc., based in Pennington, New Jersey.

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