Approval Date: April 17, 1995
I. GENERAL INFORMATION:
Wade Jones Company
Highway 71 North
Lowell, Arkansas 72745
Penicillin G Potassium
Over the Counter (OTC)
- Established Name: Penicillin G Potassium
- Trade/Proprietary Name: SOLU-PEN
- Dosage Form: Soluble Powder
- How Supplied: PENICILLIN G POTASSIUM USP SOUUBLE POWDER is supplied in 8.4 ounce (241 g) glass bottles or polyfoil packet.
- How Dispensed: OTC
- Amount of Active Ingredients: 0.384 billion units penicillin G potassium
- Species: Turkeys
- Labeled Dosage and Administration: Administer orally at a dosage of 1,500,000 units of penicillin per gallon (3.8 liters) of drinking water for 5 consecutive days.
- Pharmacological Category: Antibiotic
- Indications for Use: PENICILLIN G POTASSIUM USP SOLUBLE POWDER is indicated for treatment of erysipelas in turkeys (caused by Erysipelothrix rhusiopathiae).
- Pioneer/NADA #: Solvay/Penicillin G Potassium USP®, NADA 55-060
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, Wade Jones Company was granted a waiver from conducting an in vivo bioequivalence study for PENICILLIN G POTASSIUM USP. The generic and pioneer products contain the same active ingredient and are administered as drinking water solutions.
III. HUMAN FOOD SAFETY:
The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.01 ppm is already established for uncooked edible tissues of turkeys [21 CFR 556.510(c)].
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 penicillin G potassium soluble powder [21 CFR 520.1696b], discontinue treatment at least 1 day prior to slaughter. Not for use in turkeys producing eggs for human consumption.
The analytical method for the determination of penicillin G potassium 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.
Attachments: The following generic labeling and currently approved pioneer labeling are attached.
- Generic labels:
- Wade Jones Company 8.4 oz. Packet label, pg 1
- Wade Jones Company 8.4 oz. Jar label, pg 2
- Pioneer label
- Solvay 8.4 oz. Jar label, pg 3