Animal & Veterinary
ANADA 200-236 chlortetracycline HCl soluble powder - original approval
Approval Date: Sept. 24, 1997
I. GENERAL INFORMATION
|Sponsor:||Phoenix Scientific, Inc.|
3915 South 48th Street Terrace
P.O. Box 6457
St. Joseph, MO 64506-0457
|Generic Name:||chlortetracycline HCl soluble powder|
|Trade Name:||chlortetracycline HCl soluble powder|
II. TARGET ANIMAL SAFETY and DRUG EFFECTIVIENESS
Under the provisions of the Federal Food, Drug, and Cometic 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 is approved based on demonstration 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 1996). Based on the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product Chlortetracycline HCl Soluble Powder. The generic product is administered as an oral solution and contains the same active and inactive ingredients in the same concentration as the pioneer product.
III. HUMAN FOOD SAFETY
The tolerances established for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues of beef cattle, nonlactating dairy cows, calves, swine, sheep, chickens, turkeys, and ducks, as follows: (21 CFR 556.150) (a) 2 parts per million (ppm) in muscle. (b) 6 ppm in liver (c) 12 ppm in fat and kidney
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. The withdrawal time for Chlortetracycline HCl Soluble Powder is established under 21CFR 520.445b(b) - swine 5 days, chickens and turkeys 24 hours.
Regulatory Methods 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 CONCLUTIONS
This ANADA satisfies the requirements of 512 of the act and demonstrates that Chlortetracycline HCl Soluble Powder when used under its proposed conditions of use, is safe and effective for the labeled indications. The approval provides for use of Chlortetracycline HCl Soluble Powder for the treatment of disease in swine, chickens and turkeys. ADM's Chlortet™ Soluble-O (the pioneer product) for use in swine, chickens and turkeys is currently on the market as an OTC product. Therefore, the Center for Veterinary Medicine has concluded that this generic product should have OTC marketing status.
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