Approval Date: December 17, 1996
I. GENERAL INFORMATION:
Phoenix Scientific, Inc.
3915 S. 48th St. Terrace
St. Joseph, Missouri 64506-0457
Tetracycline Hydrochloride Soluble Powder-324
Over the Counter (OTC)
II. TARGET ANIMAL SAFETY AND EFFECTIVENESS
Under the provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988, 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 and drug effectiveness data and human food safety data (other than tissue residue data) are not required for approval of an ANADA. The ANADA sponsor relies on the target animal safety and 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. 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 (61 FR 26182, May 24, 1996, Bioequivalence Guidance).
Based upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver from the requirements of an in vivo bioequivalence study for the generic product, Tetracycline HCl Soluble-324 powder. The generic product contains the same active and inactive ingredients in the same concentrations as the pioneer product. The products are administered as oral solutions.
III. HUMAN FOOD SAFETY
The tolerances established for the pioneer product apply to the generic product. The tolerances established for edible uncooked tissues of calves, swine, chickens and turkeys are: 2 ppm for muscle, 6 ppm for liver, and 12 ppm for kidney and fat.
When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal times established for the pioneer product apply to the generic product. The withdrawal times are: 5 days for calves and 4 days for swine, chickens and turkeys.
Regulatory Method for Residues
The regulatory analytical method for detection of residues of the drug is a microbiological test using Bacillus cereus var. mycoides suspension. The method is as 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 Tetracycline HCl Soluble powder, when used under its proposed conditions of use, is safe and effective for the labeled indications.
- Exhibit A: Facsimile labeling for generic Tetracycline HCl Soluble Powder
2 lb. bag and a 6 item shipping carton label.
- Exhibit B: Facsimile labeling for generic Tetracycline HCl Soluble Powder
5 lb. bag and a 6 item shipping carton label.
- Exhibit C: Approved pioneer label and package insert, Fementa's Tetracycline HCl soluble powder-324, NADA 65-496, distributed by Agri-Labs.
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