Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate: what the FDA reviewed for dog products
7 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Canine; Dogs.
Products
- GBC Ointment™ (NADA/ANADA 200-287)
- Otomax® (NADA/ANADA 140-896)
- Tri-Otic® Ointment (NADA/ANADA 200-229)
- Vetro-Max® (NADA/ANADA 200-283)
Tri-Otic® Ointment NADA 200-229, Original approval, April 04, 1998; sponsor Med-Pharmex, Inc.; species: Dogs; foi_id 1772; FDA PDF
Indication
Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin.
Dose regimen
4 drops (2 drops from the 215 g bottle) for dogs under 30 lbs; 8 drops (4 drops from the 215 g bottle) for dogs 30 lbs or more, Otic (instilled into the ear canal); external ointment, twice daily, Therapy should continue for 7 consecutive days; do not use in dogs with known perforation of eardrums
Instill 4 drops (2 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8 drops ( 4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs. or more. Therapy should continue for 7 consecutive days.
Effectiveness
No study. ANADA approved on a waiver of the in vivo bioequivalence requirement based on formulation characteristics (labelled here as the bioequivalence basis, not a clinical study).; result: In vivo bioequivalence waiver granted; same active and inactive ingredients in the same concentrations as the pioneer (Otomax, NADA 140-896).
Based on the formulation characteristics of the generic product, Med-Pharmex, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product Tri-Otic Ointment (gentamicin sulfate, betamethasone valerate and clotrimazole ointment). The generic product is administered as a topical ointment and contains the same active and inactive ingredients in the same concentrations as the pioneer product.
Extraction notes: Original ANADA (generic of Otomax). No new safety, effectiveness or PK studies; effectiveness field records the bioequivalence waiver only. Summary has no Species/Class field; 'Dogs' taken from the indication ('canine') and human food safety section ('indicated for use only on dogs').
GBC Ointment™ NADA 200-287, Supplemental approval, August 23, 2006; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 1041; FDA PDF
Indication
Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin.
Dose regimen
2 drops for dogs under 30 lbs; 4 drops for dogs 30 lbs or more, Topical (otic; instilled into the ear canal), twice daily, Therapy should continue for 7 consecutive days
Instill 2 drops of TRIPLEMAX twice daily to the ear canal of dogs weighing less than 30 lbs. Instill 4 drops twice daily into the ear canal of dogs weighing 30 lbs or more. Therapy should continue for 7 consecutive days.
Effectiveness
No study. ANADA approved on a waiver of the in vivo bioequivalence requirement based on formulation characteristics (labelled here as the bioequivalence basis, not a clinical study).; result: In vivo bioequivalence waiver granted; similar active ingredients in the same concentration and dosage form as the pioneer (OTOMAX, NADA 140-896).
Based on the formulation characteristics of the generic product, IVX Animal Health, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product TRIPLEMAX (gentamicin sulfate, USP, betamethasone valerate, USP, and clotrimazole, USP) Ointment.
Extraction notes: Supplemental ANADA; sponsor in the summary is IVX Animal Health, Inc. Effect of supplement: 'The effect of the supplement is to add an additional package size, 40 g fill in a 2 oz. bottle.' No new studies; effectiveness field records the bioequivalence waiver only.
Tri-Otic® Ointment NADA 200-229, Supplemental approval, February 27, 2006; sponsor Med-Pharmex, Inc.; species: Dogs; foi_id 1006; FDA PDF
Indication
Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin.
Dose regimen
4 drops (2 drops from the 215 g bottle) for dogs under 30 lbs; 8 drops (4 drops from the 215 g bottle) for dogs 30 lbs or more, Topical (otic; instilled into the ear canal), twice daily
Instill 4 drops (2 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8 drops (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs. or more.
Effectiveness
No study. ANADA approved on a waiver of the in vivo bioequivalence requirement based on formulation characteristics (labelled here as the bioequivalence basis, not a clinical study).; result: In vivo bioequivalence waiver granted; same active ingredients, concentration and dosage form as the pioneer (OTOMAX, NADA 140-896).
Based on the formulation characteristics of the generic product, Med-Pharmex, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product TRI-OTIC (gentamicin sulfate, USP, betamethasone valerate, USP, and clotrimazole, USP) Ointment.
Extraction notes: Supplemental ANADA: effect of supplement is 'The addition of a 15 gram bottle package size made from a new material MDPE, instead of the existing LDPE or HDPE used in other sizes.' No new studies; effectiveness field records the bioequivalence waiver only. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.
GBC Ointment™ NADA 200-287, Supplemental approval, January 21, 2005; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 1040; FDA PDF
Indication
Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin.
Dose regimen
2 drops for dogs under 30 lbs; 4 drops for dogs 30 lbs or more, Topical (otic; instilled into the ear canal), twice daily, Therapy should continue for 7 consecutive days
Instill 2 drops of TRIPLEMAX twice daily to the ear canal of dogs weighing less than 30 lbs. Instill 4 drops twice daily into the ear canal of dogs weighing 30 lbs or more. Therapy should continue for 7 consecutive days.
Effectiveness
No study. ANADA approved on a waiver of the in vivo bioequivalence requirement based on formulation characteristics (labelled here as the bioequivalence basis, not a clinical study).; result: In vivo bioequivalence waiver granted; same active ingredient, concentration and dosage form as the pioneer (OTOMAX, NADA 140-896).
Based on the formulation characteristics of the generic product, Phoenix Scientific, Inc., was granted a waiver from the requirements for an in vivo bioequivalence study for the generic product TRIPLEMAX (gentamicin sulfate, USP; betamethasone valerate, USP; and Clotrimazole, USP Ointment).
Extraction notes: Supplemental ANADA; the summary names the product TRIPLEMAX (catalogue name GBC Ointment). Effect of supplement: 'This supplement provides for an additional package size, 20-gram fill in a 30 mL bottle.' No new studies; effectiveness field records the bioequivalence waiver only. The single PK-term sentence flagged in the batch plan is the generic waiver language about absorption, not PK data.
Vetro-Max® NADA 200-283, Original approval, June 01, 2006; sponsor Fougera Pharmaceuticals, LLC; species: Dogs; foi_id 1037; FDA PDF
Indication
Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin.
Dose regimen
4 drops from the 7.5 g and 15 g tubes (2 drops from the 215 g bottle) for dogs under 30 lbs; 8 drops from the tubes (4 drops from the 215 g bottle) for dogs 30 lbs or more, Topical (otic; instilled into the ear canal), twice daily
Instill 4 drops from the 7.5 g and 15 g tubes (2 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8 drops from the 7.5 g and 15 g tubes (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs. or more.
Effectiveness
No study. ANADA approved on a waiver of the in vivo bioequivalence requirement based on formulation characteristics (labelled here as the bioequivalence basis, not a clinical study).; result: In vivo bioequivalence waiver granted to Altana Inc. based on formulation characteristics; pioneer is OTOMAX (NADA 140-896).
The generic product is administered as an ointment, contains the same active ingredients in the same concentration and dosage form as the pioneer product, and contains no inactive ingredients that may significantly affect the absorption of the active ingredient.
Extraction notes: Original ANADA (generic of Otomax); sponsor in the summary is Altana Inc. (catalogue lists Fougera). No new studies; effectiveness field records the bioequivalence waiver only. The waiver sentence itself contains a PDF extraction break ('requirem ent') so the following sentence is quoted instead.
Otomax® NADA 140-896, Original approval, June 09, 1993; sponsor Intervet, Inc.; species: Canine; foi_id 1368; FDA PDF
Indication
Treatment of acute and chronic otitis externa in dogs associated with bacteria susceptible to gentamicin and/or yeast (Malassezia pachydermatis / Pityrosporum canis)
Dose regimen
4 drops (dogs 30 pounds or less) or 8 drops (dogs over 30 pounds) per ear; 2 or 4 drops from the 215 g bottle, Otic, applied directly into infected ears, twice a day, seven days
Administer 4 drops (2 drops from the 215 g bottle) for dogs weighing 30 pounds or less and 8 drops (4 drops from the 215 g bottle) for dogs weighing over 30 pounds, twice a day for seven days.
Target-animal safety
dose multiples 1X, 3X, 5X, placebo, untreated control; duration 21 consecutive days, twice a day (32-day test duration); right ears cauterized and infected with S. aureus; animals Six male and six female treated dogs (4, 12 or 20 drops); 4 placebo dogs (20 drops) and 4 untreated controls.
To determine the safety of OTOMAX when 4 (1X), 12 (3X) or 20 (5X) drops are administered into the ear canals of dogs twice a day for 21 consecutive days.
| Finding | Quote |
|---|---|
| Emesis only in 5X dogs after 5-6 days | Emesis was seen only in 5X dogs after 5-6 days of treatment. |
| Treatment-related changes limited to lower edema score and emesis at 5X (typical steroid responses) | Treatment related changes were limited to a lower edema score in treated vs. untreated control and placebo groups and emesis at 5X after 5-6 days of treatment. |
| Overt and hematological changes attributed to the infection model | Most overt and all hematological changes appeared to be directly or indirectly related to the infection model used. |
| All animals maintained weight | All animals in the study maintained their weight. |
| Conclusion: well tolerated at 1, 3 and 5X for prolonged therapy | In conclusion, OTOMAX administered otically, even at 1, 3, and 5X doses and for prolonged therapy, is well tolerated by the target species. |
Effectiveness
Blinded, randomized, positive-controlled (Panolog Ointment) multi-center clinical field study (V87-008); otitis externa with both bacterial and M. pachydermatis infection; label dose twice daily for 7 days; re-examination 2-4 days after treatment; n = 58 cases (of 341 dogs presented); primary endpoint: Clinical signs (discomfort, inflammation, swelling, exudate) and microbiology (gram-stained smears, culture) after 7 days of treatment vs Panolog Ointment; result: No statistically significant differences vs Panolog for clinical parameters or overall evaluations; OTOMAX significantly reduced Malassezia on roll smears; Panolog eliminated more Staphylococcus spp. (3 of 3); OTOMAX judged safe and effective and equivalent in adverse reactions
A total of 341 dogs of various breeds, ages, weights, and both sexes were presented for diagnosis and treatment of otitis externa with both bacterial and M. pachydermatisinfections. There were 58 cases which met the inclusion criteria and these were subsequently included in this study.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Any adverse reaction (field study; 341 dispensed test articles) | 8 | 5 | Adverse Reactions: A total of 13 cases of 341 dispensed test articles (both OTOMAX and Panolog Ointment) exhibited adverse reactions (8 for OTOMAX; 5 for Panolog Ointment). |
Extraction notes: 1993 summary; General Information has no Species/Class field, study sections state 'Species: Canine'. Effectiveness quote preserves the PDF extraction artifact 'pachydermatisinfections'. Component-efficacy studies C-6-87 (28 beagles, induced S. aureus/M. pachydermatis otitis; OTOMAX superior to placebo and clotrimazole, not different from Topagen) and V89-010 (36 dogs; 1% clotrimazole eliminated M. pachydermatis in 88% by Day 10 vs 0% placebo) are the pivotal component studies but are not captured in the effectiveness block. OTOMAX field adverse reactions listed: redness of pinna and skin (1), redness and bumps on pinna (1), scratching and snorting (1), discomfort during cleaning or medication (5); control = Panolog Ointment.
GBC Ointment™ NADA 200-287, Original approval, March 28, 2003; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 1039; FDA PDF
Indication
Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin.
Dose regimen
2 drops for dogs under 30 lbs; 4 drops for dogs 30 lbs or more, Topical (otic; instilled into the ear canal), twice daily
Instill 2 drops of GBC Ointm ent™ twice daily into ear canal of dogs weighing less than 30 lbs and 4 drops of GBC Ointment™ twice daily into the ear canal of dogs weighing 30 lbs or more.
Effectiveness
No study. ANADA approved on a waiver of the in vivo bioequivalence requirement based on formulation characteristics (labelled here as the bioequivalence basis, not a clinical study).; result: In vivo bioequivalence waiver granted to Phoenix Scientific, Inc. on May 5, 1997; pioneer is Otomax (NADA 140-896).
The generic and pioneer products contain the same active and inactive ingredients in a similar formulation as the pioneer.
Extraction notes: Original ANADA (generic of Otomax). No new studies; effectiveness field records the bioequivalence waiver only. Quotes reproduce PDF extraction artifacts verbatim ('Ointm ent', 'suscecptible'). Labeled dose (2/4 drops) differs from the 4/8-drop tube dosing of other generics because this product is supplied only in 10 g and 215 g dropper bottles. Sponsor in the summary is Phoenix Scientific, Inc. (catalogue lists Cronus Pharma).
Reproduce: foi_structured_search(query="Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).