Betamethasone Valerate, Gentamicin Sulfate: what the FDA reviewed for dog products
5 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Betamethasone Valerate, Gentamicin Sulfate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs; Dogs and cats.
Products
- Betagen™ Topical Spray (NADA/ANADA 200-188)
- GB Topical Spray (NADA/ANADA 200-388)
- Gentamicin Sulfate Topical Spray (NADA/ANADA 200-415)
- Gentamicin Topical Spray (NADA/ANADA 200-416)
- VET BETA-GEN® (NADA/ANADA 200-183)
GB Topical Spray NADA 200-388, Original approval, April 07, 2009; sponsor Dechra Veterinary Products LLC; species: Dogs; foi_id 1137; FDA PDF
Indication
Treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
Dose regimen
2 depressions of the sprayer head (each delivers 0.7 ml) held 3 to 6 inches from the lesion, Topical (spray), 2 to 4 times daily, for 7 days
Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days. Each depression of the sprayer head delivers 0.7 ml of Gentamicin Sulfate With Betamethasone Valerate Topical Spray.
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 (GENTOCIN Topical Spray, NADA 132-338).
Based on the formulation characteristics of the generic product, American Pharmaceuticals & Cosmetics. Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product GB Topical Spray (gentamicin sulfate, betamethasone valerate).
Extraction notes: Original ANADA (generic of Gentocin Topical Spray); sponsor in the summary is American Pharmaceuticals & Cosmetics, Inc. (catalogue lists Dechra). Each mL contains gentamicin sulfate equivalent to 0.57 mg gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone. No new studies; effectiveness field records the bioequivalence waiver only.
Gentamicin Sulfate Topical Spray NADA 200-415, Original approval, January 12, 2007; sponsor First Priority, Inc.; species: Dogs; foi_id 1147; FDA PDF
Indication
Treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
Dose regimen
Two depressions of the sprayer head (each delivers 0.7 mL), Topical (spray), 2 to 4 times daily, for 7 days
Two depressions of the sprayer head 2 to 4 times daily for 7 days. Each depression of the sprayer head delivers 0.7 mL of Gentamicin Sulfate Topical Spray.
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 (GENTOCIN Topical Spray, NADA 132-338).
Based on the formulation characteristics of the generic product, First Priority, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product Gentamicin Sulfate Topical Spray (gentamicin sulfate, betamethasone valerate).
Extraction notes: Original ANADA (generic of Gentocin Topical Spray). Each mL contains gentamicin sulfate equivalent to 0.57 mg gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone. No new studies; effectiveness field records the bioequivalence waiver only.
Betagen™ Topical Spray NADA 200-188, Original approval, January 29, 1997; sponsor Med-Pharmex, Inc.; species: Dogs; foi_id 1424; FDA PDF
Indication
Treatment of infected superficial lesions in dogs caused by bacteria sensitive to gentamicin
Effectiveness
Generic (ANADA) approval; in vivo bioequivalence waived (September 8, 1992) based on formulation characteristics; safety and effectiveness established by chemical equivalence to the pioneer Gentocin Topical Spray (NADA 132-338); result: Bioequivalence waiver granted; no additional safety, efficacy or in vivo bioequivalency studies required
Based on the formulation characteristics of the generic product, Med-Pharmex Inc was granted a waiver September 8, 1992 from conducting an in vivo bioequivalence study with Gentocin Topical Spray.
Extraction notes: ANADA with biowaiver; no studies and no dosage regimen stated in the summary (only composition: each mL gentamicin sulfate equivalent to 0.57 mg gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone).
VET BETA-GEN® NADA 200-183, Original approval, July 31, 1995; sponsor Med-Pharmex, Inc.; species: Dogs and cats; foi_id 1441; FDA PDF
Indication
Treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin
Dose regimen
3 to 8 drops into the ear canal (otitis externa); sufficient amount to cover the treatment area (superficial infected lesions), Topical, twice daily, seven to fourteen days; duration and/or frequency may be reduced depending on severity and response
Otitis externa- Instill 3 to 8 drops of Gentavet Otic Solution (approximately room temperature) into the ear canal twice daily for seven to fourteen days. Superficial infected lesions- Apply a sufficient amount of Gentavet Otic Solution to cover the treatment area twice daily for seven to fourteen days.
Effectiveness
Generic (ANADA) approval; in vivo bioequivalence waived (July 17, 1990) based on formulation characteristics; safety and effectiveness established by chemical equivalence to the pioneer Gentocin Otic Solution (NADA 046-821); result: Bioequivalence waiver granted; no additional safety, efficacy or in vivo bioequivalency studies required
Based on the formulation characteristics of the generic product, Med Pharmex Inc was granted a waiver July 17, 1990 (photocopy attached) from conducting an in vivo bioequivalence study with Gentavet Otic Solution.
Extraction notes: Catalogue lists the product as VET BETA-GEN but the 1995 FOI text names it Gentavet Otic Solution. No Species/Class field; species taken from 'labeled for use in dogs and cats only' and the canine/feline indication. ANADA with biowaiver; no studies.
Gentamicin Topical Spray NADA 200-416, Original approval, November 10, 2011; sponsor Sparhawk Laboratories, Inc.; species: Dogs; foi_id 1148; FDA PDF
Indication
Treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
Dose regimen
Two depressions of the sprayer head, Topical (spray), 2 to 4 times daily, for 7 days
Two depressions of the sprayer head 2 to 4 times daily for 7 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; solution with the same active ingredient, concentration and dosage form as the RLNAD (GENTOCIN Topical Spray, NADA 132-338).
Based on the formulation characteristics of the generic product, Sparhawk Laboratories, Inc. was granted a waiver from the requirement for an in vivo bioequivalence study for the generic product Gentamicin Topical Spray (gentamicin sulfate, betamethasone valerate).
Extraction notes: Original ANADA (generic of Gentocin Topical Spray). Summary states CVM did not require effectiveness or target animal safety studies for this approval (sentences not quoted because of PDF extraction breaks). Each milliliter contains gentamicin sulfate equivalent to 0.57 mg gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone.
Reproduce: foi_structured_search(query="Betamethasone Valerate, Gentamicin Sulfate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).