Approval Date: June 26, 1995
I. GENERAL INFORMATION:
Rhone Merieux, Canada, Inc.
345 Boul. Labbe Blvd, N.
Victoriaville, QC, G6P lB 1
Over the Counter (OTC)
- Established Name: Oxytetracycline Hydrochloride
- Trade/Proprietary Name: Undetermined
- Dosage Form: Soluble Powder
- How Supplied: OXYTETRACYCLINE HCL SOLUBLE POWDER 9.87 oz packet or 3.09 lb bottle
- How Dispensed: OTC
- Amount of Active Ingredients: 166 grams Oxytetracycline HCL per pound of powder
- Species: Chickens, Turkeys and Swine
- Labeled Dosage and Administration: Administer in water proportioners at a dosage of 1 oz of stock solution to 1 gallon (3.8 liters) of drinking water and administer for 7 to 14 days to poultry, and 5 days to swine.
- Pharmacological Category: Antibiotic
- Indications for Use:
- OXYTETRACYCLINE HCL SOLUBLE POWDER is for control of Mycoplasma synoviae, M. gallisepticum, Escherichia coli, and Pasteurella multocida in Chickens.
- for control of Hexamita meleagridis, Mycoplasma synoviae, transmissible eneritis and coronaviral enteritis in Turkeys.
- for control and treatment of Escherichia coli, Salmonella choleraesuis, Pasteurella multiocida and Leptospira pomona in Swine.
- Pioneer/NADA #: I.D. Russell's Oxytet Soluble ®, NADA 130-435.
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, Rhone Merieux formally, Sanoff Sante Animale, Canada, Inc. was granted a waiver from conducting an in vivo bioequivalence study for OXYTETRACYCLINE HYDROCHLORIDE. 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 3 ppm is established for uncooked kidney and a tolerance of 1 ppm is established for uncooked muscle, liver, fat and skin in chickens and turkeys (21 CFR 556.500(a)). A tolerance of 0.1 ppm is established for the uncooked edible tissues of swine (21 CFR 556.500(b)).
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 times for oxytetracycline HC1 soluble powder are established under 21 CFR 520.1660d: 13 days for swine; 5 days for turkeys; zero days for chickens; oxytetracycline HC1 soluble powder is not for use in chickens or turkeys producing eggs for human consumption.
Regulatory-Method for Residues
The analytical method for the detection of residues of oxytetracycline is a microbiological test using Bacillus cereus var. mycoides. This method may be found in Antibiotic Residues in Milk, Dairy-Products, and Animal Tissues: Methods, Reports, and Protocols, revised October 1968, reprinted December 1974. National Center for Antibiotic and Insulin Analysis, FDA, Washington, DC 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 oxytetracycline hydrochloride 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:
- Sanoff Sante 9.87 oz (280 g) Packet label, pg 1
- Pioneer label
- Sanoff Sante 3.09 lb (1400 g) bottle label, pg 2
- I. D. Russell 9.87 oz (280 g) Packet label, pg 3
- I. D. Russell 3.09 lb (1400 g) bottle label, pg 4
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