Approval Date: February 8, 1993
I. GENERAL INFORMATION:
P.O. Box 3103
St. Joseph, MO 64503
gentamicin 100 mg/mL solution
Gentamicin Sulfate Solution
Dosage Form: Solution
How Supplied: 100 mL multiple dose vials
How Dispensed: Rx
Amount of Active Ingredients: Each mL contains gentamicin sulfate equivalent to 100 mg gentamicin base.
Route of Administration: Uterine Infusion
Recommended Dosage: 20 to 25 mL (2.0 -2.5 grams) of Gentamicin per day for 3 to 5 days during estrus.
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses 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 by Schering Plough Animal Health Corporation.
Date of Approval: February 8, 1993
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). New target animal safety data and drug effectiveness data, were not required for approval of this ANADA. This ANADA relies on the target animal safety and drug effectiveness data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. Bioequivalence is usually demonstrated through a clinical end-point study.
For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990). Based upon the formulation characteristics of the generic product, AgriLabs, Ltd. was granted a waiver from conducting an in vivo bioequivalence study for gentamicin sulfate solution. The generic and pioneer products are solutions with the same active and inactive ingredients. The generic and pioneer products also contain the same concentration of active ingredient. This ANADA was granted a waiver January 3, 1990 (see attachment).
III. HUMAN FOOD SAFETY:
Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of this ANADA. This drug is labeled for use in horses not intended for food.
IV. AGENCY CONCLUSIONS:
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that gentamicin sulfate solution, when used under its proposed conditions of use, is safe and effective for its labeled indications.
- Gentamicin sulfate solution product label
- Gentamicin sulfate solution package insert
- Gentocin® solution product label
- Gentocin® solution package 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