Approval Date: March 24, 1997
I. GENERAL INFORMATION
2727 Thompson Creek Road
Pomona, California 91767
Gentasol (gentamicin sulfate solution)
A. Established Name: gentamicin sulfate
B. Trade/Proprietary Name: Gentasol (gentamicin sulfate solution)
C. Dosage Form: Solution to be diluted in water for egg dipping
D. How Supplied: 2-2/3 fl oz (80 mL) bottle
E. How Dispensed: OTC
F. Amount of Active Ingredient: 50 mg/mL
G. Route of Administration: Dip
H. Species: Turkey eggs
I. Labeled Dosage: A concentration of 500 ppm is recommended. To make a solution of approximately 500 ppm gentamicin activity, mix one bottle of Gentasol Solution for turkey egg dipping to each 2 gallons water.
J. Indications for Use: For the reduction or elimination of the following organisms from turkey hatching eggs: Arizona hinshawii (paracolon), Salmonella st. paul, Mycoplasma meleagridis.
K. Pioneer Product/"Listed Product": Garasol® Solution (Gentamicin Sulfate Veterinary) (Schering, NADA 092-523)
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 54060, 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, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety data, drug effectiveness, and human food safety data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. 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, Med-Pharmex, Inc. was granted a waiver from conducting an in vivo bioequivalence study for gentamicin sulfate solution. The generic and pioneer products contain the same active and inactive ingredients in the same concentration and are solutions.
III. HUMAN FOOD SAFETY
The tolerances established for the pioneer product apply to the generic product. Since eggs that have been dipped in gentamicin sulfate solutions are not intended for use as food, a tolerance for residues has not been established.
When a waiver of the in vivo bioequivalence study is granted, the withdrawal times are those previously assigned to the pioneer product. Since the drug is to be used in the dipping treatment of turkey hatching eggs only, and since the eggs dipped in the solution are not intended for food, there is no withdrawal time assigned to the solution.
Regulatory Method for Residues
Since eggs that have been dipped in gentamicin sulfate solutions are not intended for use as food, a regulatory method for residues has not been established.
IV. AGENCY CONCLUSIONS
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the Act and demonstrates that gentamicin sulfate solution when used under the proposed conditions of use, is safe and effective for its labeled indications..
The following generic labeling and currently approved pioneer labeling are attached.
- Facsimile bottle label and insert for generic gentamicin sulfate - Gentasol (Gentamicin Sulfate Solution) 50 mg/mL, 80 mL bottles
- Approved pioneer bottle labeling and insert for gentamicin sulfate - Garasol (Gentamicin Sulfate Veterinary) 50 mg/mL, 80 mL bottles
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855