FDA clears first generic ketoprofen injectable for BRD fever in cattle
Bottom line
FDA has approved a supplemental abbreviated new animal drug application for KetoMed (ketoprofen injectable solution), giving Bimeda’s product a cattle indication for the control of pyrexia associated with bovine respiratory disease, or BRD. That makes KetoMed the first FDA-approved generic ketoprofen injectable labeled for this use in cattle, expanding on the product’s original March 22, 2021 approval for horses. The generic references Zoetis’ brand-name Ketofen, which gained its cattle BRD fever indication on May 25, 2021. According to FDA and the brand’s FOI summary, ketoprofen is labeled in beef heifers, beef steers, beef calves 2 months and older, beef bulls, replacement dairy heifers, and dairy bulls, and is not for use in lactating dairy cattle, dairy calves, veal calves, calves under 2 months, or reproducing animals over 1 year of age. (animaldrugsatfda.fda.gov)
Why it matters: For veterinarians managing BRD, the approval adds a new generic NSAID option for fever control within an already familiar indication, which could help with cost discussions, formulary flexibility, and protocol design in beef and non-lactating dairy cattle. FDA notes that approved veterinary NSAIDs require veterinary oversight, and the Ketofen cattle approval documents underscore the usual class considerations, including gastrointestinal and renal risk, as well as labeled use restrictions in certain cattle classes. More broadly, BRD remains one of the most significant health and economic challenges in U.S. cattle practice, and published reviews suggest NSAIDs can play a useful ancillary role in reducing pyrexia and improving short-term clinical response when used alongside appropriate case management. (fda.gov)
What to watch: Watch for the updated KetoMed cattle label, distribution timing, and whether the new generic meaningfully changes BRD treatment economics or hospital and feedlot protocols. (animaldrugsatfda.fda.gov)
Key facts
- Product
- KetoMed (ketoprofen injectable solution)
- Approval
- FDA supplemental abbreviated new animal drug application
- New indication
- Control of pyrexia associated with bovine respiratory disease in cattle
- First generic
- First FDA-approved generic ketoprofen injectable labeled for this use in cattle
- Original approval
- March 22, 2021, for horses
- Reference product
- Zoetis' Ketofen
- Ketofen cattle approval
- May 25, 2021
- Labeled cattle classes
- Beef heifers, beef steers, beef calves 2 months and older, beef bulls, replacement dairy heifers, and dairy bulls
- Not for use in
- Lactating dairy cattle, dairy calves, veal calves, calves under 2 months, or reproducing animals over 1 year of age
The FDA has approved the first generic ketoprofen injectable for control of fever associated with bovine respiratory disease in cattle, extending Bimeda’s KetoMed label beyond its original equine use. The move gives veterinarians a generic counterpart to Zoetis’ Ketofen for a narrowly defined, but clinically relevant, BRD indication: pyrexia control in beef and certain non-lactating dairy classes of cattle. (animaldrugsatfda.fda.gov)
The background here matters. KetoMed was first approved by FDA on March 22, 2021 as an abbreviated new animal drug application for horses, based on equivalence to the reference listed drug Ketofen. Separately, Zoetis’ Ketofen received a supplemental cattle approval on May 25, 2021 for control of pyrexia associated with BRD. FDA’s FOI materials for that supplement describe the cattle indication as a new target animal and indication added to the existing ketoprofen product. The current supplemental generic approval effectively brings that same cattle fever-control indication into the generic market. (animaldrugsatfda.fda.gov)
Label specifics are important for practice use. FDA’s public materials for Ketofen state the cattle indication covers beef heifers, beef steers, beef calves 2 months of age and older, beef bulls, replacement dairy heifers, and dairy bulls. The product is not for use in lactating dairy cattle, dairy calves, veal calves, calves under 2 months of age, or reproducing animals over 1 year of age. In the original branded cattle approval, Zoetis supported the indication with a multi-site field study in high-risk beef calves showing significantly more treatment successes in ketoprofen-treated cattle than controls, using a success definition tied to rectal temperature reduction 6 hours after treatment. (animaldrugsatfda.fda.gov)
The regulatory mechanics also help explain why this matters. FDA says generic animal drugs are approved through the ANADA pathway, which requires the sponsor to show bioequivalence to the approved reference drug rather than repeat the full slate of effectiveness and target animal safety studies required for an original NADA. That’s the same framework FDA highlighted in other recent cattle generic approvals, including the January 22, 2026 approval of nixiFLOR, the first generic florfenicol and flunixin meglumine injectable for BRD and associated pyrexia. In other words, this ketoprofen decision fits a broader pattern of FDA gradually widening the generic toolkit available to food-animal veterinarians. (fda.gov)
Direct expert reaction to this specific approval was limited in public sources, but the broader industry view on ancillary BRD therapy is fairly consistent. FDA notes that NSAIDs in cattle are used to control fever associated with BRD, mastitis, and endotoxemia, while also warning that the class can affect the kidneys and gastrointestinal tract. Published reviews and survey work suggest veterinarians commonly view NSAIDs as an important adjunct in BRD management, especially for reducing pyrexia and improving comfort, even as antimicrobial selection and case definition remain central to treatment success. (fda.gov)
Why it matters: For cattle veterinarians, a first generic in this category is less about changing the standard of care than about adding flexibility. A generic ketoprofen injectable for BRD-associated fever may support more cost-sensitive treatment plans, especially in feedlot and stocker settings where protocol economics matter. It also gives practices another labeled NSAID option to consider when building BRD treatment bundles around antimicrobial therapy, animal welfare goals, and residue compliance. At the same time, the label boundaries remain critical: this is a fever-control claim, not a standalone BRD treatment claim, and the usual NSAID cautions around dehydration, kidney disease, and gastrointestinal effects still apply. (animaldrugsatfda.fda.gov)
There’s also a practical formulary angle. Zoetis already markets ketoprofen in cattle and a tulathromycin-ketoprofen combination product for BRD-associated pyrexia, so many veterinarians will already know where ketoprofen fits clinically. The generic approval could create pricing pressure or improve access, though whether that happens will depend on launch timing, channel uptake, and how aggressively distributors position the product against existing BRD-supportive therapy options. That last point is an inference based on how generic animal drug approvals typically affect market dynamics, not a claim FDA has made. (zoetisus.com)
What to watch: The next signals will be the updated KetoMed cattle labeling, commercial rollout details from Bimeda, and whether practices begin revising BRD protocols to incorporate the generic as a routine antipyretic option in eligible cattle classes. (animaldrugsatfda.fda.gov)