Florfenicol, Mometasone furoate, Terbinafine: what the FDA reviewed for dog products
4 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Florfenicol, Mometasone furoate, 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
- CLARO™ (NADA/ANADA 141-440)
- Florfinasone™ Otic (NADA/ANADA 200-848)
- Klentz™ (NADA/ANADA 200-829)
- SIMPLERA™ (NADA/ANADA 200-719)
Florfinasone™ Otic NADA 200-848, Original approval, April 08, 2026; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 18375; FDA PDF
Indication
Treatment of otitis externa in dogs associated with susceptible strains of Malassezia pachydermatis and Staphylococcus pseudintermedius.
Dose regimen
1 dropperette (1 mL) per affected ear, Otic, Single administration, One dose per affected ear; to be administered by veterinary personnel
Administer one dose (1 dropperette) per affected ear.
Effectiveness
Bioequivalence waiver (no in vivo or clinical study): biowaiver granted on formulation characteristics (solution with the same active ingredients and concentrations as the RLNAD CLARO, NADA 141-440); result: Biowaiver granted; product deemed safe and effective by reference to CLARO
Based on the formulation characteristics of the generic product, Cronus Pharma Specialities India Pvt Ltd., was granted a biowaiver for the generic product Florfinasone™ Otic (florfenicol, terbinafine, mometasone furoate) otic solution.
Extraction notes: Generic (ANADA) approval (2026) with a biowaiver; the summary contains no animal studies, PK, safety or adverse-reaction data. The 'effectiveness' entry records the biowaiver only. The parsed general_information section is missing for this summary (sponsor field truncated), so fields were taken from the raw text.
Klentz™ NADA 200-829, Original approval, December 22, 2025; sponsor Aurora Pharmaceutical, Inc.; species: Dogs; foi_id 17828; FDA PDF
Indication
Treatment of otitis externa in dogs associated with susceptible strains of Malassezia pachydermatis and Staphylococcus pseudintermedius.
Dose regimen
1 dropperette (1 mL) per affected ear, Otic, Single administration, One dose per affected ear; to be administered by veterinary personnel
Administer one dose (1 dropperette) per affected ear.
Effectiveness
Bioequivalence waiver (no in vivo or clinical study): biowaiver granted on formulation characteristics (solution with the same active ingredients and concentrations as the RLNAD CLARO, NADA 141-440); result: Biowaiver granted; product deemed safe and effective by reference to CLARO
Based on the formulation characteristics of the generic product, Aurora Pharmaceutical, Inc., was granted a biowaiver for the generic product Klentz™ (florfenicol, terbinafine, mometasone furoate) otic solution.
Extraction notes: Generic (ANADA) approval (2025) with a biowaiver; the summary contains no animal studies, PK, safety or adverse-reaction data. The 'effectiveness' entry records the biowaiver only.
CLARO™ NADA 141-440, Original approval, September 20, 2015; sponsor Elanco US Inc.; species: Dogs; foi_id 931; FDA PDF
Indication
Treatment of otitis externa in dogs associated with susceptible strains of Malassezia pachydermatis and Staphylococcus pseudintermedius.
Dose regimen
1 dropperette (1 mL) per affected ear, Otic, Single administration, One dose per affected ear, administered by a veterinarian after cleaning the ear canal
Administer one dose (1 dropperette) per affected ear.
Target-animal safety
dose multiples 0X, 1X, 3X, 5X; duration Every 2 weeks on Study Days 1, 15 and 29 (three administrations) into both ear canals; animals 12 male and 12 female treated plus 8 controls (4 male and 4 female).
Twenty-four Beagle dogs (12 male and 12 female), 12 weeks of age at enrollment, were administered CLARO and 8 dogs (4 male and 4 female) were administered a placebo control (saline).
| Finding | Quote |
|---|---|
| All dogs survived; no clinically relevant effects on body weight, hearing or food consumption; post-treatment ear wetness/clear aural exudate | All dogs survived to scheduled necropsy. No clinically relevant treatment-related findings were noted in body weight, weight gain, hearing tests, or food consumption. Dogs administered CLARO were found to have post-treatment ear wetness or clear aural exudate. |
| Dose-dependent suppression of adrenal cortical response to ACTH stimulation at all dose levels, more pronounced on Day 30 | There was dose-dependent suppression of the adrenal cortical response to ACTH-stimulation on both Days 2 and 30 of the dosing phase in all groups administered CLARO; this effect was more pronounced on Day 30 of the dosing phase. |
| Lower adrenal weight with cortical atrophy, higher liver/gall bladder weight with hepatocellular enlargement, decreased thymus weight | This was accompanied by lower group mean and individual adrenal gland weight and atrophy of the zona fasciculata/reticularis of the adrenal cortex. Higher group mean and individual animal liver/gall bladder weight parameters occurred with corresponding hepatocellular enlargement/cytoplasmic change. There was a decrease in thymus weight not associated with microscopic lymphoid depletion. |
| Hematology/chemistry shifts (neutrophils up in 5X males, lymphocytes and eosinophils down, AST up at all doses) within reference ranges | There was an increased group mean absolute neutrophil count in males in the 5X group, and decreased absolute lymphocyte and eosinophil counts, and increased AST in dogs administered CLARO at all dose levels. |
Effectiveness
Randomized (2:1), vehicle-controlled, multi-center (8 U.S. clinics) field study (P13-004) of a single 1 mL per ear administration after saline cleaning; 221 dogs enrolled (146 CLARO, 75 vehicle), 183 evaluable for effectiveness; n = 120 CLARO and 63 control (effectiveness analysis); primary endpoint: Treatment success on Day 30: total otitis externa clinical score of 3 or less (erythema, exudate, swelling, ulceration each 0-3) with no individual sign worsening; result: Success 72.5% CLARO vs 11.1% vehicle (P-value = 0.0001); effective against S. pseudintermedius (58 successes/16 failures) and M. pachydermatis (85/23)
The effect iveness analysis included 120 dogs in the CLARO group and 63 dogs in the control group. T here were 87 successfully treated cases and 33 failures in the CLARO group, and 7 successes and 56 failures in the control group.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Abnormal integument (Table 4; columns CLARO N=146, control N=75) | 6 | 1 | Abnormal integument (erythema, pyoderma, flea allergy dermatitis, pruritus, lipoma, etc.) 6 1 |
| Coughing, tracheobronchitis (Table 4) | 2 | 1 | Coughing, tracheobronchitis 2 1 |
| Limping, arthritis (Table 4) | 2 | 1 | Limping, arthritis 2 1 |
| Red eyes, conjunctivitis, blepharospasm (Table 4) | 2 | 0 | Red eyes, conjunctivitis, blepharospasm 2 0 |
| Aural hematoma (Table 4) | 1 | 0 | Aural hematoma 1 0 |
| Adverse reactions directly attributable to CLARO (field study) | There were also no adverse reactions directly attributable to administration of CLARO. |
Extraction notes: Original approval (2015, corrected FOI summary). No PK section (topical otic product); an in vitro non-interference/MIC study is in the effectiveness section but not extracted as PK. Target animal safety quotes the GLP margin-of-safety study in 12-week-old Beagles (0X/1X/3X/5X of 1 mL/ear every 2 weeks x3); the control group received 5 mL/ear saline. The effectiveness quote reproduces OCR artefacts ('effect iveness', 'T here') verbatim. Adverse event rows are counts only (Table 4); remaining single-dog rows (cervical pain, diarrhea, lethargy, sneezing, trauma, tympanic membrane thickening, urinary incontinence, urinary tract infection) omitted.
SIMPLERA™ NADA 200-719, Original approval, September 28, 2022; sponsor Vetoquinol USA, Inc.; species: Dogs; foi_id 12934; FDA PDF
Indication
Treatment of otitis externa in dogs associated with susceptible strains of Malassezia pachydermatis and Staphylococcus pseudintermedius.
Dose regimen
1 dropperette (1 mL) per affected ear, Otic, Single administration, One dose per affected ear
Administer one dose (1 dropperette) per affected ear.
Effectiveness
Bioequivalence waiver (no in vivo or clinical study): biowaiver granted on formulation characteristics (solution with the same active ingredients and concentrations as the RLNAD CLARO, NADA 141-440); result: Biowaiver granted; product deemed safe and effective by reference to CLARO
Based on the formulation characteristics of the generic product, Vetoquinol USA, Inc., was granted a biowaiver for the generic product SIMPLERA™ (florfenicol, terbinafine, mometasone furoate) otic solution.
Extraction notes: Generic (ANADA) approval (2022) with a biowaiver; the summary contains no animal studies, PK, safety or adverse-reaction data. The 'effectiveness' entry records the biowaiver only. Indication quote reproduces the source spacing artefact 'f or' verbatim.
Reproduce: foi_structured_search(query="Florfenicol, Mometasone furoate, Terbinafine") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).