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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-102 Gentaglyde™ Solution - original approval

Approval Date: May 19, 1994

I. GENERAL INFORMATION:

NADA200-102
Sponsor:Fort Dodge Laboratories
800 5th Street
Fort Dodge, Iowa 50501
Generic Name:gentamicin sulfate solution
Trade Name:Gentaglyde™ Solution
Marketing Status:Prescription

 

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 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, Fort Dodge Laboratories was granted a waiver December 13, 1989 (photocopy attached) from conducting an in vivo bioequivalence study with Gentaglyde Solution. 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, Gentaglyde Solution (gentamicin sulfate, 100 mg/mL), were established by demonstration of chemical equivalence to the pioneer product, Schering-Plough Animal Health Corporation's Gentocin(R) 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, consistent with FDA policy implementing Section 512(b)(2) of the FFD&C Act, no additional safety, efficacy, or in vivo bioequivalence studies were necessary or required.

This ANADA satisfies the requirements of section 512 of the Act and demonstrates that Gentaglyde Solution is safe and effective for its labeled indications when used under its proposed conditions of use.

 

V. Attachments:

Copy of waiver letter.
Generic Labeling:

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

Pioneer Labeling:

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

Copies of these attachments may be obtained by writing to the:

Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855