Approval Date: August 4, 1995
I. GENERAL INFORMATION:
Fermenta Animal Health Company
10150 North Executive Hills Blvd.
Kansas City, Missouri 64153
gentamicin sulfate solution
Gentamicin Sulfate Solution 100 mg/mL
Amount of Active Ingredients: Each mL contains gentamicin sulfate equivalent to 100 mg gentamicin base
Route of Administration: Intrauterine infusion
Labeled Dosage: 20 to 25 mL (2.0 to 2.5 grams) Gentamicin Sulfate Solution per day for 3 to 5 days during estrus
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Pioneer Product: Gentocin® Solution (gentamicin sulfate, 100 mg/mL), NADA 046-724, Schering-Plough Animal Health Corporation
Date Stamped: August 4, 1995
II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS:
Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act (53 FR 50460, December 15, 1988; first GADPTRA Policy Letter), an Abbreviated New Animal Drug Application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). For certain dosage forms, the Agency grants a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; fifth GADPTRA Policy Letter). In lieu of bioequivalence testing, the safety and efficacy of the generic product are based on the demonstrated chemical equivalence to the pioneer product.
Based on the formulation characteristics of the generic product, Fermenta Animal Health Company was granted a waiver November 19, 1990, (photocopy attached) from conducting an in vivo bioequivalence study with Gentamicin Sulfate Solution 100 mg/mL. The generic and pioneer products are solutions with the same inactive ingredients and the same concentrations of the active ingredient.
III. HUMAN SAFETY:
Human Safety Relative to Food Consumption: Regarding consumption of drug residues in food, human safety data were not required for approval of this ANADA. This drug is labeled for use in horses not intended for food.
Human Safety Relative to Possession, Handling and Administration: Labeling contains adequate caution/warning statements.
IV. AGENCY CONCLUSIONS:
This is an Abbreviated New Animal Drug Application (ANADA) filed under Section 512(b)(2) of the Federal, Food, Drug and Cosmetic (FFD&C) Act. Safety and effectiveness for this generic animal drug, Gentamicin Sulfate Solution 100 mg/mL, were established by demonstration of chemical equivalence to the pioneer product, Schering-Plough Animal Health Corporation's Gentocin® Solution (gentamicin sulfate, 100 mg/mL, NADA 046-724).
This generic product and the pioneer product have identical labeling indications for use. The route and method of administration of the two drugs are identical. Both drugs are administered by intrauterine infusion. The generic and pioneer products are both solutions that contain the same active and inactive ingredients in the same concentrations. Both products have the same pH. Therefore, in compliance with FDA policy promulgated to implement Section 512(b)(2) of the FFD&C Act, no additional safety, efficacy, or in vivo bioequivalency studies were necessary or required.
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that Gentamicin Sulfate Solution 100 mg/mL is safe and effective for its labeled indications when used under its proposed conditions of use.
- Copy of waiver letter.
- Generic (FINAL) and Pioneer Labeling (MOST CURRENT).
- Generic product label.
- Generic product insert.
- Pioner product bottle label.
- Pioneer product box label.
- Pioneer product insert.
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855