Approval Date: March 28, 1996
I. GENERAL INFORMATION
Phoenix Scientific, Inc.
3915 S. 48th St. Terrace
PO Box 6457
St. Joseph, MO 64506-0457
Generic Name: tripelennamine hydrochloride
Trade Name: Tripelennamine Hydrochloride Injection
Dosage Form: Injectable solution
How Supplied: 250 and 500 mL vial sizes
Marketing Status: Rx
Amount of Active Ingredient: 20 mg/mL
Route of Administration: IM in horses, IV or IM in cattle.
Species: Cattle and horses
Labeled Dosage: 2.5 mL per 100 lb of body weight IM in horses and IV or IM in cattle.
Indications for Use: For use in cattle and horses in conditions in which antihistaminic therapy may be expected to lead to the alleviation of some signs of disease. Dose may be repeated in 6 to 12 hours if necessary.
Pioneer Product: Re-Covr® Injection, NADA 006-417
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 (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990).
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, Tripelennamine HCl Injection. The generic product is administered as a solution and contains the same active and inactive ingredients in the same concentration as the pioneer product.
III. HUMAN FOOD SAFETY
A tolerance has not been established for tripelennamine HCl.
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 tripelennamine HCl injection in cattle are: four days following the last treatment for the edible tissues and 24 hours (two milkings) after the last treatment for milk. Tripelennamine is not for use in horses intended for food.
Regulatory Method for Residues
An official analytical method for the detection of residues of tripelennamine in tissues and milk has not been designated.
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 Tripelennamine Hydrochloride Injection, when used under its proposed conditions of use, is safe and effective for the labeled indications.
- Exhibit A: Facsimile vial labeling for generic Tripelennamine Hydrochloride Injection (250mL and 500 mL)
- Exhibit B: Facsimile package insert for generic Tripelennamine Hydrochloride Injection (250mL and 500 mL)
- Exhibit C: Approved pioneer vial label and package insert for Re-Covr® Injection for 100 mL.
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855