The U.S. Food and Drug Administration has approved Bimasone, an injectable solution for the treatment of certain anti-inflammatory responsive diseases in dogs, cats and horses. Bimasone, the first generic FDA-approved flumethasone, is sponsored by Ireland-based Bimeda Animal Health Ltd.
The corticosteroid drug contains the same active ingredient in the same concentration and dosage form as Zoetis Inc.’s Flucort Solution, which was first approved in October 1965.
Generic veterinary drugs undergo an FDA premarket review to obtain legal marketing status. During the review, the agency evaluates information submitted by the drug company to ensure the product is safe and effective for its intended use.
Veterinarians should welcome generic drugs, said Stephen Ettinger, DVM, DACVIM (SAIM, Cardiology).
“Substituting a veterinary generic for a brand-name veterinary drug should be automatic for veterinarians, similar to the human medical profession, where physicians adopt generic drugs at a rate of 80% within one year of a generic drug’s launch,” he said.
Bimasone is recommended for the following indications:
- Equine: Used intravenously, intramuscularly or intra-articularly to treat musculoskeletal conditions caused by inflammation when no permanent structural changes exist and for allergic conditions such as hives and insect bites.
- Canine: Used intravenously, intramuscularly, intralesionally or subcutaneously to treat musculoskeletal conditions caused by inflammation of muscles, joints and associated structures with no permanent structural changes; dermatologic conditions such as pruritus and irritation; otitis externa in conjunction with topical medication; and allergic conditions such as hives, urticaria and insect bites.
- Feline: Used intravenously, intramuscularly or subcutaneously to treat acute and chronic dermatologic conditions.
“As veterinarians, we should embrace the use of FDA-approved veterinary generic drugs, because they are bioequivalent to their brand-name counterparts, making them safe and effective, and they cost less than brand medicines,” Dr. Ettinger said.