First generic firocoxib chewable tablets approved by the FDA for dogs

Officials with the FDA have approved the first generic firocoxib chewable tablets (Firox; Norbrook Laboratories) for the control of pain and inflammation associated with osteoarthritis in dogs, and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.

Firocoxib chewable tablets contain the same active ingredient in the same concentration and dosage form as the approved brand name drug product (Previcox; Boehringer Ingelheim), which was first approved on July 21, 2004, according to the FDA. Firocoxib is a nonsteroidal anti-inflammatory drug (NSAID). Like many NSAIDs, firocoxib works by affecting certain enzymes that trigger pain, fever, and inflammation.

Firocoxib chewable tablets, like other veterinary NSAIDs, are only available by prescription because a veterinarian’s expertise is required to determine if the medication is an appropriate treatment and to monitor pet health while taking the drug.

Veterinarians and pet owners should be aware of the potential risks associated with the use of NSAIDs and should ensure all dogs undergo a thorough history and physical examination, including appropriate blood and urine tests, before beginning NSAID therapy. According to the FDA, common adverse effects include vomiting, diarrhea, not eating or eating less, and lethargy. Administering the medication should stop and a veterinarian immediately contacted if a pet experiences any of these potential adverse effects.

Veterinarians should provide the Firox Client Information Sheet with each prescription and refill of the generic product, which is available as half-scored tablets in 2 strengths: containing 57 mg or 227 mg firocoxib. Each tablet strength is supplied in 60 count and 180 count bottles.

Reference

FDA approves the first generic firocoxib chewable tablets for dogs. FDA. March 28, 2022. Accessed March 28, 2022. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-firocoxib-chewable-tablets-dogs