Approval Date: October 18, 1994
I. GENERAL INFORMATION:
Sanofi Animal Health, Inc.
7101 College Boulevard-Suite 610
Overland Park, KS 66210
penicillin G potassium, USP
Penicillin G Potassium, USP
Over the Counter (OTC)
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 penicillin G potassium soluble powder. The generic and pioneer products contain the same active ingredient and are water soluble powders administered as oral solutions. The generic product contains no inactive ingredients that may significantly affect the absorption of the active ingredient.
III. HUMAN FOOD SAFETY:
The tolerance established for the pioneer product applies to the generic product. A tolerance of 0.01 ppm in uncooked edible tissues of turkeys is listed under 21 CFR 556.510 for penicillin G potassium.
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 potassium penicillin G in drinking water (21 CFR 540.181b), discontinue treatment at least 1 day prior to slaughter of the turkeys. Not to be used in turkeys producing eggs for human consumption.
The analytical method for the determination of penicillin 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 penicillin G potassium 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 available.
- Facsimile primary container (HPDE Bottle) label for generic penicillin G potassium, USP
- Facsimile secondary container (Case) label for generic penicillin G potassium, USP
- Approved pioneer package label penicillin G potassium, USP
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