Gentamicin, Mometasone furoate, posaconazole: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Gentamicin, Mometasone furoate, posaconazole, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Mometamax Single™ (NADA/ANADA 141-600)
Mometamax Single™ NADA 141-600, Original approval, April 29, 2025; sponsor Intervet, Inc.; species: Dogs; foi_id 16869; FDA PDF
Indication
Treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.
Dose regimen
0.8 mL per affected ear, Otic (instilled into the external ear canal), Once (single administration), Administered by veterinary personnel; each 0.8 mL dose delivers 6.88 mg gentamicin, 2.08 mg posaconazole and 1.68 mg mometasone furoate; ear canal cleaned before dosing in the field study
The dose volume is 0.8 mL per affected ear.
Target-animal safety
dose multiples 0X, 1X, 3X, 5X; duration Three administrations at two-week intervals (Days 1, 15 and 29); necropsy Day 31; animals 32.
Study Animals: Thirty-two (32) healthy Beagle puppies (16 males and 16 females), 11- to 12- weeks of age and 2.8 to 5.0 kg body weight at first treatment.
| Finding | Quote |
|---|---|
| Mild eosinopenia at 3X and 5X and suppression of serum cortisol | Mometamax Single™ administration was associated with mild eosinopenia in the 3X and 5X groups and suppression of serum cortisol levels. |
| Low pre-ACTH cortisol in 2/8 dogs at 1X and all dogs at 3X and 5X | On Day 30 prior to ACTH administration, two of eight dogs in the 1X group had below normal cortisol levels, all dogs in the 3X group had cortisol levels of <0.2 µg/dL, and all dogs in the 5X group had below normal cortisol levels (seven having a cortisol level of <0.2 µg/dL). |
| Lower adrenal weights in 3X/5X females and 5X males | The mean adrenal weights in 3X and 5X group females and the 5X group males were statistically lower than control values. |
| Mild atrophy of ear canal epidermis and tympanic membrane surface at 1X, 3X and 5X | Histopathology demonstrated mild atrophy of the external auditory canal epidermis and mild atrophy of the external surface of the tympanic membrane in the 1X, 3X, and 5X groups. |
| No test article effects on survival, clinical observations, otoscopic/hearing/ophthalmic exams, ECG or gross pathology | Results: No test article-related effects were observed on survival, clinical observations, veterinary physical examinations, body weights, food consumption, otoscopic examinations, hearing assessments, ophthalmic examinations, coagulation, clinical chemistry, urinalysis, fecal evaluations, electrocardiography parameters, or gross pathology. |
Effectiveness
Randomized, double-masked, vehicle-controlled, multi-center field study (Study S16068-00; 17 US sites); single 0.8 mL dose per affected ear on Day 0; 372 dogs enrolled (245 Mometamax Single, 127 vehicle) with 254 in the effectiveness analysis; n = 163 Mometamax Single, 91 vehicle control (effectiveness analysis); primary endpoint: Treatment success on Day 33: total otitis externa clinical score of 3 or less (erythema, swelling, ulceration, exudate) with no individual score worse than Day 0; result: Success rate 80.5% (123/163) vs 19.6% (15/91) for vehicle; p<0.0001
The effectiveness analysis included 163 dogs in the Mometamax Single™ group and 91 dogs in the vehicle control group. The success rate in Mometamax Single™ -treated dogs was 80.5%, compared to 19.6% in the vehicle control group.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 21 (8.6%) | 4 (3.1%) | Vomiting 21 (8.6%) 4 (3.1%) |
| Decreased appetite | 9 (3.7%) | 2 (1.6%) | Decreased appetite 9 (3.7%) 2 (1.6%) |
| Pruritus | 8 (3.3%) | 2 (1.6%) | Pruritus 8 (3.3%) 2 (1.6%) |
| Ear pruritus | 7 (2.9%) | 1 (0.8%) | Ear pruritus 7 (2.9%) 1 (0.8%) |
| Disorientation | 3 (1.2%) | 0 (0.0%) | Disorientation 3 (1.2%) 0 (0.0%) |
Extraction notes: No plasma PK reported; dosage characterization used ear-wax depletion studies (drug detectable in healthy ears for at least ~30 days). Adverse reaction rows are from Table II.5 of the field study; column order is Mometamax Single (N=245) then vehicle control (N=127). The General Information dosage field in the parsed metadata is a table-of-contents artifact; the dose quote is from the Dosage Regimen paragraph. Margin-of-safety study was in 11-12-week-old puppies dosed in both ears (0X control received mineral oil at the 5X volume).
Reproduce: foi_structured_search(query="Gentamicin, Mometasone furoate, posaconazole") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).