FDA Approves the First Generic Firocoxib Tablets for Horses

The U.S. Food and Drug Administration announced on August 1 that it has approved the first generic firocoxib tablets for pain and inflammation associated with osteoarthritis in horses. 

Firocoxib Tablets for Horses contain the same active ingredient (firocoxib) in the same concentration and dosage form as the approved brand name drug product, Equioxx Tablets, which was first approved on July 24, 2016.  

Firocoxib is a non-steroidal 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. Firocoxib Tablets for Horses, like other veterinary NSAIDs, are only available by prescription because a veterinarian’s expertise is required to determine if Firocoxib Tablets for Horses is an appropriate treatment and to monitor animal health while taking the drug.  

Veterinarians and animal owners should be aware of the potential risks associated with the use of NSAIDs. Serious side effects associated with NSAID therapy in horses can occur with or without warning. The most common side effects associated with firocoxib therapy involve the tongue, lips and skin of the mouth and face (erosions and ulcers of the mucosa and skin) and the kidney. Gastrointestinal, kidney and liver problems have also been reported with other NSAIDs.  

Veterinarians should provide the Firocoxib Tablets for Horses Client Information Sheet with each prescription and refill of the product. 

Firocoxib Tablets for Horses are available as half-scored tablets in 57 mg of firocoxib and are to be administered once daily for up to 14 days. The tablets are supplied in 60-count bottles. 

The New Animal Drug Application for Firocoxib Tablets for Horses is sponsored by Pegasus Laboratories, Inc. based in Pensacola, Florida.  

For more information: 

• Freedom of Information Summary 
• Client Information Sheets – Take-Home Safety Knowledge
• Veterinary NSAIDs