FDA Approves First Generic Flumethasone for Certain Anti-inflammatory Responsive Diseases in Cats, Dogs and Horses

 April 5, 2023

Today the U.S. Food and Drug Administration approved Bimasone Injectable Solution, the first generic flumethasone, for certain diseases that cause inflammation in horses, dogs, and cats. Bimasone is recommended for the various rheumatic, allergic, dermatologic and other disease states that are known to be responsive to anti-inflammatory drugs (i.e., corticoids) in these species.

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

In horses, Bimasone is approved for use for musculoskeletal conditions due to inflammation, such as bursitis (a painful condition that affects the fluid-filled sacs that cushion the bones, tendons and muscles near a horse’s joints, often in the hip or shoulder), carpitis (inflammation of the connective tissues near the horse’s carpus, which is comparable to the human wrist), osselets (arthritis in the fetlock joint of a horse, often in the front legs), and myositis (rapid muscle wasting, often in the horse’s hindquarters).

In dogs, Bimasone is approved for use for musculoskeletal conditions due to inflammation of muscles or joints, such as arthritis, osteoarthritis, intervertebral disc disease, and myositis. The drug has proven useful in treating canine ear infections (otitis externa) when used with topical medication for similar reasons. It is also approved for certain acute and chronic skin conditions (dermatoses) from various causes to help control the itchy skin (pruritus), irritation, and inflammation associated with these conditions, and for use in treating allergic reactions, such as hives, urticaria (raised itchy rash on skin), and insect bites. Bimasone is also approved for treating shock in dogs, when administered intravenously.

In cats, Bimasone is approved for certain acute and chronic skin conditions (dermatoses) from various causes to help control the itchy skin (pruritus), irritation, and inflammation associated with these conditions.

Bimasone is only available by prescription from a licensed veterinarian because professional veterinary expertise is needed to determine whether Bimasone is an appropriate treatment.

Bimasone is supplied in a 0.5mg/mL concentration in 100 mL multi-dose vials.

Bimasone is sponsored by Bimeda Animal Health Ltd., based in Dublin, Ireland.

100ml PP vaccine vial

250ml PE plastic vaccine bottle

Source from FDA: https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-flumethasone-certain-anti-inflammatory-responsive-diseases-cats-dogs-and