The supplemental approval expands KetoMed’s existing label to include a new species and indication, offering veterinarians a generic alternative to the brand-name Ketofen.
US 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.
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Clinical Target: BRD—frequently referred to as “shipping fever pneumonia”—remains a major operational threat to the economics of U.S. beef and dairy herds.
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Protocols: Formulated at 100 mg/mL, the bioequivalent drug is cleared for beef heifers, steers, calves (minimum 2 months old), bulls, and replacement dairy heifers. Due to its prescription classification and strict food safety standards, the FDA has mandated a rigid 48-hour meat withdrawal period alongside a 0.36 ppm marker residue tolerance threshold in kidney tissues.
