FDA Approves Generic Ketoprofen for Control of Fever in Cattle with Bovine Respiratory Disease
June 3, 2026
The U.S. Food and Drug Administration has issued a supplemental approval for KetoMed (ketoprofen) injectable solution for the control of pyrexia (fever) associated with Bovine Respiratory Disease (BRD) in beef heifers, beef steers, beef calves at least 2 months old, beef bulls, replacement dairy heifers, and dairy bulls. BRD is an infectious condition commonly referred to as “shipping fever pneumonia.” This is the first generic approval of a ketoprofen injectable solution for this indication.
The FDA approved KetoMed in 2021 for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. This supplemental approval adds the new BRD-related pyrexia indication in cattle.
KetoMed contains the same active ingredient as the approved brand-name product, Ketofen. The FDA has determined that KetoMed is bioequivalent to the brand-name product.
Ketoprofen, the active ingredient in KetoMed, is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting the production of prostaglandins – substances made by the body that contribute to signs of inflammation such as fever.
In cattle, KetoMed is administered by subcutaneous injection once daily. The product can be administered for up to three days if fever persists. It is available by prescription from a licensed veterinarian, as professional expertise is required to accurately diagnose BRD and monitor the safe use of the product.
KetoMed is not for use in reproducing cattle more than one year old, dairy calves, or veal calves. It is also not for use in lactating dairy cattle or calves less than two months old.
KetoMed is sponsored by Bimeda Animal Health Ltd., based in Ireland.
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