FDA Approves First Generic Robenacoxib Injectable for Postoperative Pain and Inflammation in Dogs and Cats

March 9, 2026

The U.S. Food and Drug Administration today approved Robenacoxib Injection (robenacoxib), the first generic injectable robenacoxib for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs at least four months of age, and for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats at least four months of age.

Robenacoxib Injection contains the same active ingredient (robenacoxib) as the approved brand-name drug product, Onsior injection, which was first approved for dogs in 2016 and cats in 2015. The FDA determined that Robenacoxib Injection is bioequivalent to the brand-name product.

Robenacoxib Injection is a non-steroidal anti-inflammatory drug (NSAID) and is only available via a prescription from a licensed veterinarian. Robenacoxib Injection can be given once daily for up to three days.

Robenacoxib Injection is sponsored by Cronus Pharma Specialities India Private Ltd.

Additional Information

• Freedom of Information Summary – Robenacoxib Injection (ANADA 200-804) 
• Veterinary Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
• What Veterinarians Should Advise Clients About Pain Control and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Dogs and Cats