Betamethasone Acetate, Terbinafine: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Betamethasone Acetate, Terbinafine, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- DuOtic® (NADA/ANADA 141-579)
DuOtic® NADA 141-579, Original approval, March 15, 2024; sponsor Dechra Veterinary Products LLC; species: Dogs; foi_id 15165; FDA PDF
Indication
Treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis)
Dose regimen
1 tube (1 mL) per affected ear, Otic (external ear canal), twice, 7 days apart, administered by a veterinary professional; do not clean the ear canal for 45 days after the initial administration
Administer one dose (1 tube) per affected ear and repeat administration in 7 days.
Effectiveness
Randomized, double-masked, placebo-controlled, multi-center field study (US and Spain; Study D20028, GLP); 1:1 DuOtic 1 mL per affected ear vs saline on Days 0 and 7; 239 dogs enrolled (120 DuOtic, 119 placebo); n = 197 (102 DuOtic, 95 placebo) in effectiveness evaluation; primary endpoint: Treatment success on Day 45: Overall Severity Score ≤3 in the evaluable ear with no worsening of any individual clinical sign vs Day 0; result: Success rate 62.31% DuOtic vs 17.84% placebo (back-transformed least squares estimates); p = 0.0001
A total of 197 dogs (102 DuOtic™ and 95 placebo control) were included in the effectiveness evaluation. The success rate on Day 45 in the DuOtic™ treated group was 62.31% versus 17.84% for the placebo control group
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Elevated alanine aminotransferase | 4 (3.3%) | 0 (0.0%) | Elevated alanine aminotransferase* 4 (3.3%) 0 (0.0%) |
| Conjunctivitis | 1 (0.8%) | 0 (0.0%) | Conjunctivitis 1 (0.8%) 0 (0.0%) |
| Ocular discharge | 1 (0.8%) | 2 (1.7%) | Ocular discharge 1 (0.8%) 2 (1.7%) |
| Ear discharge | 0 (0.0%) | 1 (0.8%) | Ear discharge 0 (0.0%) 1 (0.8%) |
| Ear pruritus | 3 (2.5%) | 4 (3.4%) | Ear pruritus 3 (2.5%) 4 (3.4%) |
Extraction notes: Target animal safety is supported by reference to the Osurnia TAS study (NADA 141-437); no TAS study in this summary, so target_animal_safety is null. No PK. Adverse reaction rows quoted from flattened Table II.4: term, DuOtic n (%) of n=120, placebo n (%) of n=119. Terbinafine MIC50/MIC90 for M. pachydermatis 0.12/0.5 μg/mL (338 isolates).
Reproduce: foi_structured_search(query="Betamethasone Acetate, Terbinafine") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).