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  1. CVM Updates

FDA Approves the First Generic Firocoxib Chewable Tablets for Dogs


March 28, 2022

Today the U.S. Food and Drug Administration approved the animal drug Firox, the first generic firocoxib chewable tablets indicated for the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.

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

Although NSAIDs are effective medications for pain and inflammation, there are potential risks associated with their use. Firox, like other veterinary NSAIDs, is only available by prescription because a veterinarian’s expertise is required to determine if Firox 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. Common side effects that can occur when a dog is receiving NSAID therapy include vomiting, diarrhea, not eating/eating less, and lethargy, and pet owners should stop administering the medication if any of these side effects occur. 

Veterinarians should provide the Firox Client Information Sheet with each prescription and refill of the product.

Firox is available as half-scored tablets in two strengths, containing 57 mg or 227 mg firocoxib. Each tablet strength is supplied in 60 count and 180 count bottles.

Firox is sponsored by Norbrook Laboratories, Ltd., based in the United Kingdom.

For more information:

Freedom of Information Summary

Veterinary Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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