FDA Approves First Generic Ketoprofen for Use in Horses
March 23, 2021
The FDA has approved KetoMed, the first generic ketoprofen for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses.
Musculoskeletal disorders are prevalent in aging horses and can cause pain, weakness, stiffness and decreased range of motion in the animals’ joints. Osteoarthritis and chronic laminitis are among the most common musculoskeletal disorders in horses and can greatly impact a horse’s performance and quality of life.
KetoMed contains the same active ingredient (ketoprofen) in the same concentration and dosage form as the approved brand name drug product, Ketofen, which was first approved on September 26, 1990. In addition, the FDA determined that KetoMed contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.
The data submitted in support of the Abbreviated New Animal Drug Application demonstrate that KetoMed, when used according to its label, is safe and effective.
KetoMed is a prescription product because a veterinarian’s expertise is required to diagnose musculoskeletal disorders and to determine whether ketoprofen is an appropriate treatment.
KetoMed is supplied in 50 mL and 100 mL multidose bottles. The recommended dosage is 1 mg/lb (1 mL/100 lbs) of body weight once daily. Treatment is administered by intravenous injection and may be repeated for up to five days.
KetoMed is sponsored by Bimeda Animal Health Ltd. based in Dublin, Ireland.
For more information:
Freedom of Information Summary
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.