Approval Date: April 10, 1995
I. GENERAL INFORMATION
Sanofi Animal Health, Inc.
7101 College Boulevard-Suite 610
Overland Park, KS 66210
Gentamicin Sulfate Injection
- Established Name: gentamicin sulfate solution
- Trade/Proprietary Name: GENTAMICIN SULFATE INJECTION
- Dosage Form: Injectable solution.
- How Supplied: GENTAMICIN SULFATE INJECTION 100 mg/mL is supplied in 100 mL vials. Boxes contain twelve vials.
- How Dispensed: OTC
- Amount of Active Ingredients: Each mL contains gentamicin sulfate equivalent to 100 mg gentamicin base; 3.2 mg sodium metabisulfite; 0.1 mg edetate disodium; 4.5 mg sodium acetate anhydrous; 3.0 mg glacial acetic acid; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives.
- Species: Chickens, Day-old only.
- Labeled Dosage and Administration: Each day-old chicken should be aseptically injected subcutaneously in the neck with a single GENTAMICIN SULFATE INJECTION diluted with sterile, physiological saline solution to provide 0.2 mg gentamicin in a 0.2 mL dose.
- Pharmacological Category: Antibiotic
- Indications for Use: GENTAMICIN SULFATE INJECTION is indicated for use in the prevention of early mortality in day-old chickens caused by Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.
- Pioneer/NADA #: Garasol®, NADA 101-862
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, 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, 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, Sanofi Animal Health, Inc. was granted a waiver from conducting an in vivo bioequivalence study for GENTAMICIN SULFATE INJECTION. The generic and pioneer products are injectable solutions with the same active ingredient and no differences in the inactive ingredients which would affect absorption of the active ingredient.
III. HUMAN FOOD SAFETY
When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal times are those previously assigned to the pioneer product.
For gentamicin sulfate injectable [21 CFR 522.1044 (a) (d) (3)], do not slaughter treated animals for food for at least 5 weeks after treatment.
The analytical method for the determination of gentamicin in tissues uses a microbiological assay procedure. This method is found in the Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports, and Protocols, revised October 1968, National Center for Antibiotic and Insulin Analysis, FDA, Washington, D.C. 20204.
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 when used under the proposed conditions of use, is safe and effective for its labeled indications.
Attachments: The following generic labeling and currently approved pioneer labeling are attached.
- Sanofi enlarged 100 mL vial label.
- Sanofi package insert for vials.
- Schering/Plough enlarged front/sides of 80 mL vial label.
- Schering/Plough enlarged back side of vial label.
- Schering/Plough enlarged package insert for vials.