Flumethasone: what the FDA reviewed for dog products

1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Flumethasone, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Horses, dogs and cats.

Products

Bimasone™ NADA 200-612, Original approval, April 05, 2023; sponsor Bimeda Animal Health Ltd.; species: Horses, dogs and cats; foi_id 13715; FDA PDF

Indication

Rheumatic, allergic, dermatologic and other corticoid-responsive disease states. Canine indications: musculoskeletal inflammation (arthritis, osteoarthritis, disc syndrome, myositis), acute/chronic dermatoses and otitis externa, allergic states (hives, urticaria, insect bites), and shock/shock-like states by IV administration.

Dose regimen

0.0625 to 0.25 mg daily (dogs), intravenous, intramuscular or subcutaneous injection (dogs; also intra-lesional and intra-articular), daily; may be repeated if necessary, Chronic conditions: oral maintenance with flumethasone tablets at 0.0625 to 0.25 mg daily. Horses 1.25 to 2.5 mg daily; cats 0.03125 to 0.125 mg.

Canine: 0.0625 to 0.25 mg daily by intravenous, intramuscular or subcutaneous injection. If necessary, the dose may be repeated.

Extraction notes: Generic ANADA approval (RLNAD Flucort, NADA 030-414). A biowaiver was granted based on formulation characteristics; the summary contains no bioequivalence, target animal safety, effectiveness or adverse reaction data. Dose regimen recorded for dogs only.

Reproduce: foi_structured_search(query="Flumethasone") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).