Approval Date: August 1, 1997
Freedom of Information Summary
NADA 200-193
I. GENERAL INFORMATION:
NADA 200-193 Sponsor: Phoenix Scientific, Inc.
3915 South 48th Street Terrace
P.O. Box 6457
St. Joseph, MO 64506-0457Generic Name: clindamycin hydrochloride, USP Trade Name: Clindamycin hydrochloride oral liquid Marketing Status: 2. 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).
For certain dosage forms, the agency grants a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990: fifth GADPTRA Policy Letter). In lieu of in vivo bioequivalence testing, the safety and efficacy of the generic product are based on the demonstrated chemical equivalence to the pioneer product.
Based upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver on December 8, 1995, from conducting an in vivo bioequivalence study with Clindamycin Hydrochloride Oral Liquid. The generic and pioneer products are solutions with the same active and inactive ingredients.
3. HUMAN FOOD SAFETY
The product is labeled for use in dogs only, not a food producing animal. Therefore, no human food safety information is required.
Human Safety Relative to Possession, Handling and Administration:
Labeling contains adequate caution/warning statements.
4. AGENCY CONCLUSION:
This is an Abbreviated New Animal Drug Application (ANADA) filed under section 512(b)(2) of the Federal Food, Drug, and Cosmetic (FFD&C) Act.
Bioequivalence of this generic animal drug, Clindamycin Hydrochloride Oral Liquid (25 mg/mL), to the pioneer product, Upjohn's Antirobe Aquadrops (NADA 135-940), was established by demonstration of chemical equivalence.
This generic product and the pioneer product have identical labeling indications for the 20mL (0.68 fl oz.) vial for use in dogs. The route and method of administration of the two drugs are identical. Both drugs are administered orally. The generic and pioneer products contain the same active and inactive ingredients. Therefore, in compliance with FDA policy implementing section 512(b)(2) of FFD&C Act, in vivo bioequivalency studies were not required.
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that Clindamycin Hydrochloride Oral Liquid is safe and effective for its labeled indications when used under its proposed conditions of use.
Attachment:
Generic and pioneer labeling
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