Gentamicin Sulfate: what the FDA reviewed for dog products

2 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing 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 and cats.

Products

Gentamicin Sulfate Ophthalmic Solution NADA 200-576, Original approval, January 30, 2015; sponsor Domes Pharma S.A.; species: Dogs and cats; foi_id 1252; FDA PDF

Indication

Topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats.

Dose regimen

1 or 2 drops, Ophthalmic (into the conjunctival sac), 2 to 4 times a day

Instill 1 or 2 drops into the conjunctival sac 2 to 4 times a day.

Effectiveness

ANADA (generic of GENTOCIN Ophthalmic Solution, NADA 099-008): bioequivalence waiver based on formulation characteristics; CVM did not require effectiveness or target animal safety studies; result: Waiver granted; same active ingredient, concentration and dosage form as the reference listed new animal drug

Based on the formulation characteristics of the generic product, Akorn Animal Health, Inc. was granted a waiver from the requirement to demonstrate bioequivalence for the generic product Gentamicin Sulfate Ophthalmic Solution.

Extraction notes: Generic (ANADA) approval; no new studies. The single 'PK sentence' flagged in the batch plan is the waiver rationale mentioning bioavailability, not a PK value. Effectiveness field records the bioequivalence waiver only.

Vetro-Gen™ Veterinary Ophthalmic Ointment NADA 200-273, Original approval, June 08, 2004; sponsor Dechra Veterinary Products LLC; species: Dogs and cats; foi_id 1030; FDA PDF

Indication

Topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats.

Dose regimen

Approximately ½ inch strip of ointment, Topical, ophthalmic (to the affected eye(s)), 2 to 4 times a day

Apply approximately ½ inch strip of VETRO-GEN Veterinary Ophthalmic Ointment to the affected eye(s) 2 to 4 times a day.

Effectiveness

ANADA (generic of GENTOCIN Ophthalmic Ointment, NADA 98-989): in vivo bioequivalence study waived based on formulation characteristics; no effectiveness study conducted; result: Waiver granted; generic contains the same active ingredient in the same concentration and dosage form as the pioneer

Based upon the formulation characteristics of the generic product, Pharmaderm, Veterinary Division of Altana Inc. was granted a waiver from the requirement for in vivo bioequivalence study for VETRO-GEN Veterinary Ophthalmic Ointment (gentamicin sulfate).

Extraction notes: Generic (ANADA) approval; summary contains no new target animal safety, effectiveness or PK data. The effectiveness field records the bioequivalence waiver only. Sponsor at approval was Altana Inc. (catalogue lists Dechra).

Reproduce: foi_structured_search(query="Gentamicin Sulfate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).