Approval Date: July 21, 1994
I. GENERAL INFORMATION:
I.D. Russell Company
1301 Iowa Avenue
Longmont, Colorado 80501
penicillin G potassium
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 genetic 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 genetic 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, I.D. Russell Company 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 is established for the uncooked edible tissues of turkeys, 21 CFR 556.510.
When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal time is that previously assigned to the pioneer product.
The withdrawal time for penicillin G potassium is established under 21 CFR 520.1696b(b): one day for turkeys; not to be used in turkeys producing eggs for human consumption.
The regulatory analytical method for the determination of penicillin in tissues is a microbiological assay procedure. The method is published by the Food and Drug Administration, "Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports, and Protocols", revised October 1968, reprinted December 1974.
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 attached:
- Facsimile package label for generic penicillin G potassium - R-PEN
- Approved pioneer package label for penicillin G potassium - Penicillin G Potassium USP soluble powder
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