Approval Date: November 21, 1997
I. GENERAL INFORMATION:
Western Chemical, Inc.
Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Over the Counter (OTC)
II. INDICATIONS FOR USE
TRICAINE-S is intended for the temporary immobilization of fish, amphibians, and other aquatic, cold-blooded animals. It has been recognized as a valuable tool for the proper handling of these animals during manual spawning (fish stripping), weighing, measuring, marking, surgical operations, transport, photography, and research.
III. DOSAGE FORM(S), ROUTE(S) OF ADMINISTRATION AND RECOMMENDED DOSAGES AND CONTRAINDICATIONS
A. Dosage Form: The product is available in the form of a crystalline powder to be mixed in water for immersion of the animal.
B. Route(s) of Administration and Recommended Dosage: The route of administration is immersion of the animal at levels ranging from 10 to 1,000 mg/liter.
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. Instead, the ANADA sponsor must show that the generic product is bioequivalent to the pioneer. 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 (single pure active ingredient), Western Chemical, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product TRICAINE-S (tricaine methanesulfonate). The generic product is administered as an solution and contains the same active 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
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.
Do not use within 21 days of harvesting fish for food.
When used in food fish, use should be restricted to Ictaluridae, salmonidae, Esocidas, and Percidae and water temperature should not exceed 10°C (50°F).
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 TRICAINE-S, when used under its proposed conditions of use, is safe and effective for the labeled indications.
Facsimile labeling for generic TRICAINE-S:
- 3.5 oz (100 grams) and 2.2 lb. (1 kilogram)
- Approved pioneer labels and package insert for FINQUEL® sponsored by Argent Chemical, Inc.
- 3.5 oz (100 grams) and 2.2 lb. (1000 grams)
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