Animal & Veterinary

ANADA 200-115 Gentamex™ 100 - original approval (July 21, 1995)

Approval Date: July 21, 1995





Macleod Pharmaceuticals, Inc.
2600 Canton Court
Fort Collins, CO 80525

Generic Name:

gentamicin sulfate solution

Trade Name:

Gentamex™ 100

Marketing Status:


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: Intrauterine infusion

Species: Equine

Labeled Dosage: 20 to 25 mL (2.0 to 2.5 gram) Gentamex 100 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 by Schering-Plough Animal Health Corporation

Date of Approval: July 21, 1995


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 may grant 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, Macleod Pharmaceuticals was granted a waiver November 5, 1990 (photocopy attached) from conducting an in vivo bioequivalence study with Gentamex 100. The generic and pioneer products are solutions with the same inactive ingredients and the same concentrations of the active ingredient.


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.


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, Gentamex 100 (gentamicin sulfate, 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 Gentamex 100 is safe and effective for its labeled indications when used under its proposed conditions of use.


Copy of waiver letter.

Generic Labeling:

  1. Individual Bottle Carton
  2. Bottle Label
  3. Package Insert
  4. Shipper Carton Label

Pioneer Labeling (most current):

  1. Individual Bottle Carton
  2. Bottle Label
  3. Package Insert


  1. Gentamex box label
  2. Gentamex bottle label
  3. Gentamex package insert
  4. Gentamex carton label
  5. Gentocin® bottle label
  6. Gentocin® package insert
  7. Gentocin® box label

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

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