Generic corticosteroid for dogs, cats and horses receives FDA approval

Officials with the FDA have approved Bimasone Injectable Solution, the first generic flumethasone, for certain diseases that cause inflammation in horses, dogs, and cats. Sponsored by Bimeda Animal Health, this product is recommended for the various rheumatic, allergic, dermatologic, and other disease states that are known to be responsive to anti-inflammatory drugs (ie, corticoids) in these species.

Bimasone Injectable Solution is a corticosteroid drug that contains the same active ingredient (flumethasone) in the same concentration and dosage form as Flucort, the approved brand name drug product. Flucort was first approved for use in horses, dogs, and cats on October 21, 1965.

In horses, flumethasone is indicated for musculoskeletal conditions caused by inflammation, such as bursitis, carpitis, osselets, and myositis. In cats, flumethasone is indicated for certain acute and chronic skin conditions, from various causes, to help control the associated pruritus, irritation, and inflammation.

In dogs, the drug product is indicated for musculoskeletal conditions caused by inflammation of muscles or joints, such as arthritis, osteoarthritis, intervertebral disc disease, and myositis. The drug has also proven useful in treating canine otitis externa when used with topical medication for similar reasons. It is also approved for certain acute and chronic skin conditions, from various causes, to help control the associated pruritus, irritation, and inflammation, and for use in treating allergic reactions such as hives, urticaria, and insect bites. Flumethasone is also indicated for treating shock in dogs, when administered intravenously, according to the FDA.

Bimasone is supplied in a 0.5mg/mL concentration in 100 mL multi-dose vials. The drug product is only available by prescription from a licensed veterinarian.

Reference

FDA approves first generic flumethasone for certain anti-inflammatory responsive diseases in cats, dogs and horse. News release. FDA. April 5, 2023. Accessed April 5, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-flumethasone-certain-anti-inflammatory-responsive-diseases-cats-dogs-and?utm_medium=email&utm_source=govdelivery