Clotrimazole, Gentamicin Sulfate, Mometasone furoate: what the FDA reviewed for dog products

1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Clotrimazole, Gentamicin Sulfate, Mometasone furoate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.

Products

Mometavet® NADA 200-536, Original approval, May 17, 2016; sponsor Dechra Veterinary Products LLC; species: Dogs; foi_id 1225; FDA PDF

Indication

Treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. including P. aeruginosa, coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci).

Dose regimen

4 drops from the 7.5 g, 15 g or 30 g containers (2 drops from the 215 g bottle) for dogs under 30 lbs, Topical (otic), into the ear canal after cleaning and drying; eardrum must be intact, once daily, 7 consecutive days; dogs weighing 30 lbs or more receive 8 drops (4 drops from the 215 g bottle).

For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (2 drops from the 215 g bottle) once daily in the ear canal.

Extraction notes: Original ANADA (2016) generic to Mometamax (NADA 141-177). Bioequivalence waiver granted on formulation characteristics (same actives, concentrations and dosage form; no inactive ingredients affecting bioavailability); CVM required no effectiveness, target animal safety or user safety studies. The 8-drop sentence for dogs 30 lbs or more crosses a page header in the extracted text and is summarised in duration_or_conditions.

Reproduce: foi_structured_search(query="Clotrimazole, Gentamicin Sulfate, Mometasone furoate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).