March 15, 2024

Today the U.S. Food and Drug Administration approved DuOtic (terbinafine and betamethasone acetate otic gel) for the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).

DuOtic is the first FDA-approved animal drug intended to treat yeast-only otitis externa in dogs. DuOtic is also the first otic drug intended to treat otitis externa that does not contain an antibiotic. This allows veterinarians to focus treatment and avoid using antibiotics when dogs have diagnosed yeast-only ear infections.

DuOtic is a fixed combination of the two active substances: terbinafine and betamethasone acetate. Terbinafine is an antifungal and is commonly used in human medicine to treat athlete’s foot. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity.  

DuOtic dissolves in earwax and is slowly eliminated from the ear. The treatment acts to fight yeast infections for up to 45 days. 

DuOtic is only available by a prescription from a licensed veterinarian and should be administered by a veterinary professional. Veterinary professionals should clean and dry the external ear canal before administering the initial dose of the product and should administer one dose (1 tube) per affected ear and repeat administration in 7 days. The dog’s ear canal should not be cleaned for 45 days after the initial administration to allow contact of the gel with the ear canal.

DuOtic may cause eye injury and irritation in people and dogs. People who administer DuOtic in the clinic should wear eye protection, and the dog should be restrained to minimize post-application head shaking to help prevent accidental eye exposure in both people and dogs.  

DuOtic contains 10 mg terbinafine and 1 mg betamethasone acetate per mL. DuOtic is available in a single use tube with a flexible soft tip, supplied in cartons containing 2 or 20 tubes.

DuOtic is sponsored by Dechra Ltd, based in the United Kingdom.

For more information:

• Freedom of Information Summary