Approval Date: July 31, 1995

Freedom of Information Summary
NADA 200-183

I. GENERAL INFORMATION:

NADA	200-183
Sponsor:	Med-Pharmex Inc. 2727 Thompson Creek Road Pomona, CA 91767 909 593 7875
Generic Name:	Gentamicin sulfate and betamethasone valerate otic solution
Trade Name:	Gentavet® Otic Solution
Marketing Status:	Prescription

Pioneer Product:

Gentocin Otic Solution (gentamicin sulfate with betamethasone valerate, NADA 046-821) by Schering-Plough Animal Health Corporation

II. INDICATIONS FOR USE:

Gentavet Otic Solution is indicated for the treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.

III. DOSAGE

A.	DOSAGE FORM	Solution
B.	ROUTE OF ADMINISTRATION	Topical
C.	RECOMMENDED DOSAGES:	Duration of treatment will depend upon the severity of the condition and the response obtained. The duration of treatment and/or frequency of the dosage may be reduced, but care should be taken not to discontinue therapy prematurely. Otitis externa- Instill 3 to 8 drops of Gentavet Otic Solution (approximately room temperature) into the ear canal twice daily for seven to fourteen days. Superficial infected lesions- Apply a sufficient amount of Gentavet Otic Solution to cover the treatment area twice daily for seven to fourteen days.

 

IV. & V. EFFECTIVENESS AND ANIMAL TARGET

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, Med Pharmex Inc was granted a waiver July 17, 1990 (photocopy attached) from conducting an in vivo bioequivalence study with Gentavet Otic Solution. The generic and pioneer products are solutions with the same inactive ingredients and the same concentrations of the active ingredient. It is intended for topical administration.

VI. 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 dogs and cats only and should not be administered to food-producing animals.

Human Safety Relative to Possession, Handling, and Administration:

Labeling contains adequate caution/warning statements.

VII. 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, Gentavet Otic Solution, were established by demonstration of chemical equivalence to the pioneer product, Schering-Plough Animal Health Corporation's Gentocin Otic Solution, NADA 046-821). 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 topically. 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 bioequivalency studies were necessary or required.

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

VIII. LABELING (Attached):

1. Generic Labeling:

Package Insert

Immediate Container Labels: 7.5 mL, 15 mL, 240 mL
240 mL Carton Label

2. Pioneer Labeling:

Package Insert

Immediate Container Labels: 7.5 mL, 15 mL, 240 mL
240 mL Carton Label

3. Copy of waiver letter dated July 17, 1990

Copies of applicable labels may be obtained by writing to the:

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857

Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.