Approval Date: July 22, 1997
I. GENERAL INFORMATION:
2727 Thompson Creek Rd
Pomona, CA 91767-1861
tetracycline HCL soluble powder
Tetrasol soluble powder
Over the Counter (OTC)
II. INDICATIONS FOR USE
- Chickens: Control of Chronic Respiratory Disease (CRD) and air sac disease caused by Mycoplasma gallisepticum and Escherichia coli; infectious synovitis caused by Mycoplasma synoviae sensitive to tetracycline hydrochloride.
- Turkeys: Control of infectious synovitis caused by Mycoplasma synoviae and bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms susceptible to tetracycline hydrochloride.
- Swine: Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., and Klebsiella spp. sensitive to tetracycline hydrochloride.
- Calves: Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., and Klebsiella spp. sensitive to tetracycline hydrochloride
III. DOSAGE FORM(S), ROUTES(S) OF ADMINISTRATION AND RECOMMENDED DOSAGES AND CONTRAINDICATIONS
A. Dosage Form: The product is available in the form of a soluble powder for oral administration
B. Route(s) of Administration and Recommended Dosage: The route of administration is as an oral drinking water solution.
Administer Tetrasol-324 in the drinking water of swine and calves for 3 to 5 days at a drug level of tetracycline hydrochloride per gallon to provide approximately 10 mg/lb of body weight, per day in divided doses. In turkeys, for bluecomb only, administer in the drinking water for 7-14 days at a drug level of 25 mg/lb of body weight, per day in divided doses. Chickens - 200 to 800 mg/gallon.
Contraindications: There are no known contraindications to this drug when used as directed.
IV. EFFECTIVENESS AND BIOEQUIVALENCY
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 1996).
Based on the formulation characteristics of the generic product, Med-Pharmex, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product Tetrasol Soluble Powder (tetracycline hydrochloride 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.
V. ANIMAL SAFETY
Since this drug is a generic copy of the brand name drug whose safety has been established, no safety studies have been required for this application.
VI. 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.
VII. 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 (Tetrasol), when used under its proposed conditions of use, is safe and effective for the labeled indications.
- Facsimile labeling for generic Tetrasol (Tetracycline HCl Soluble Powder):
- 2 and 5 lb bag labels and a 5 oz packet label
- Approved pioneer labels and package insert, Fementa's TetraSure™ 324 (Tetracycline HCl soluble powder), NADA 65-496, distributed by Agri-Labs:
- 2 and 5 lb container labels and 5 oz packet label
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