FDA approves first generic ketoprofen injectable for fever control in cattle with BRD

The FDA has granted supplemental approval for ketoprofen injectable solution (KetoMed; Bimeda Animal Health) for the control of fever associated with bovine respiratory disease (BRD) in cattle, marking the first generic approval of a ketoprofen injectable for this indication.

BRD, commonly referred to as “shipping fever pneumonia,” is an infectious respiratory condition in cattle. The newly approved indication covers use in beef heifers, beef steers, beef calves at least 2 months old, beef bulls, replacement dairy heifers, and dairy bulls.

KetoMed was originally approved by the FDA in 2021 for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. This supplemental approval expands its labeled use to include BRD-related pyrexia in cattle.

Mechanism and administration

Ketoprofen, the active ingredient in KetoMed, is a nonsteroidal anti-inflammatory drug that works by inhibiting prostaglandin production, which is a substance involved in generating signs of inflammation, including fever.

In cattle, KetoMed contains 100 mg/mL of the active ingredient and is supplied in 50-mL and 100-mL multidose bottles.² The recommended dose is 3 mg/kg body weight, administered by subcutaneous injection once daily.² Treatment may be continued for up to 3 days if fever persists.² KetoMed is a prescription product, as veterinary oversight is required for accurate diagnosis of BRD and to ensure safe use.¹

Bioequivalence and generic status

KetoMed contains the same active ingredient as the reference listed new animal drug, Ketofen.² The FDA granted a biowaiver for the cattle indication based on an evaluation of the product formulation and relevant physicochemical properties, with bioequivalence established under the original 2021 approval.²

“The FDA has determined that KetoMed is bioequivalent to the brand-name product,” the agency wrote in an announcement.¹

Food safety and withdrawal period

A meat withdrawal period of 48 hours has been established for ketoprofen in cattle.² The acceptable daily intake for total residues of ketoprofen is 5 μg/kg of body weight per day, and a tolerance of 0.36 ppm has been set for ketoprofen as the marker residue in kidney tissue, according to the FDA.²

Labeled restrictions

KetoMed is not indicated for use in reproducing cattle more than 1 year old, dairy calves, veal calves, lactating dairy cattle, or calves younger than 2 months.¹

References

1. FDA approves generic ketoprofen for control of fever in cattle with bovine respiratory disease. FDA. June 3, 2026. Accessed June 3, 2026. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-generic-ketoprofen-control-fever-cattle-bovine-respiratory-disease
2. Freedom of information (FOI) summary: supplemental abbreviated new animal drug application (ANADA): KetoMed. Bimeda Animal Health. May 20, 2026. Accessed June 3, 2026. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18487