FDA Approves First Generic Ketoprofen for BRD Fever Control in Cattle

Cattle producers have another tool available in the fight against bovine respiratory disease after the U.S. Food and Drug Administration approved a new use for a generic ketoprofen injectable product.

The FDA recently granted supplemental approval for KetoMed, allowing the prescription drug to be used to control fever associated with bovine respiratory disease, commonly known throughout the cattle industry as shipping fever.

The approval marks the first generic ketoprofen injectable solution cleared for this specific use in cattle.

Bovine respiratory disease remains one of the most costly health challenges facing the beef industry. The illness is commonly seen in newly weaned, transported, or commingled cattle and can impact weight gain, feed efficiency, and overall herd performance.

KetoMed contains ketoprofen, a nonsteroidal anti-inflammatory drug designed to reduce fever by blocking the production of prostaglandins, naturally occurring compounds that contribute to inflammation and elevated body temperatures.

The product is approved for use in beef steers, beef heifers, beef bulls, beef calves at least two months of age, replacement dairy heifers, and dairy bulls experiencing fever associated with BRD.

Veterinarians will administer the drug through a subcutaneous injection, with treatment allowed once daily for up to three consecutive days if fever continues.

While the approval expands treatment options for producers and veterinarians, the FDA emphasized that the product remains available only by prescription. Proper diagnosis of bovine respiratory disease and monitoring of treatment outcomes require veterinary oversight.

KetoMed was originally approved in 2021 for managing pain and inflammation associated with musculoskeletal conditions in horses. The latest approval broadens its use into the cattle sector and provides producers access to a lower-cost generic alternative to the brand-name product Ketofen.

The FDA determined that KetoMed is bioequivalent to the brand-name drug, meaning it delivers the same active ingredient and performs similarly when used according to label directions.

Several restrictions remain in place. The product is not approved for use in lactating dairy cattle, dairy calves, veal calves, calves younger than two months of age, or breeding cattle older than one year.

Industry observers say the approval could help veterinarians and producers manage fever associated with respiratory disease while potentially lowering treatment costs through expanded generic availability.

KetoMed is manufactured by Ireland-based Bimeda Animal Health and is available through licensed veterinarians.