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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-028 Evict® DS and Lassie® DS Liquid Wormer plus Vet's Own™ DS Canine Anthelmintic Suspension - supplemental approval (June 4, 1997)

Approval Date: June 4, 1997

I. GENERAL INFORMATION:

NADA200-028
Sponsor:Lambert-Kay
Division of Carter-Wallace, Inc.
Half Acre Road
P.O. Box 1001
Cranbury, New Jersey 08512-0181
Generic Name:pyrantel pamoate
Trade Name:Evict® DS and Lassie® DS Liquid Wormer plus Vet's Own™ DS Canine Anthelmintic Suspension
Marketing Status:Over the Counter (OTC)
Effect of Supplement:Provides for a double strength pyrantel pamoate suspension.

Amount of Active Ingredients: Each mL contains 4.54 mg of pyrantel base as pyrantel pamoate

Route of Administration: Oral with or without food

Species: Canine (puppies and dogs)

Labeled Dosage/Indications for Use: To prevent reinfection of Toxacara canis in puppies and adult dogs and in lactating bitches after whelping. For removal of large roundworms (Toxacara canis and Toxacaris leonia) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies.

Pharmacological Category: Anthelmintic

  • Pioneer Product NENEX-2™, NADA 100-237, Pfizer Inc.

Effect of supplement: To provide for a double strength pyrantel pamoate suspension

 

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).

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 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, Lambert-Kay, Division of Carter-Wallace, Inc. was granted a waiver from conducting an in vivo bioequivalence study with pyrantel double strength. The generic and pioneer products are suspensions with the same active and similar inactive ingredients.

 

III. HUMAN SAFETY:

Human Safety Relative to Food Consumption: Regarding consumption of drug residues in food, human safety data were not required for approval of this ANADA. The drug is to be labeled for use in dogs and puppies.

Human Safety Relative to Possession, Handling and Administration: Labeling contains adequate caution/warning statements

 

IV. AGENCY CONCLUSIONS:

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.

Safety and effectiveness for this generic animal drug, pyrantel pamoate suspension, were established by demonstration of chemical equivalence to the pioneer product, Pfizer, Inc. Nemex-2™ (NADA 100-237).

This generic product and the pioneer product have identical labeling indications for use. The route and method of administration of the two drugs are identical. Both drugs are orally administered. The generic and pioneer products are both suspensions that contain the same active in the same concentration and similar inactive ingredients. Therefore, consistent with FDA policy implementing Section 512(b)(2) of the FFD&C Act, no additional safety, efficacy, or in vivo bioequivalency studies were necessary or required.

This ANADA satisfies the requirements of section 512 of the Act and demonstrates that pyrantel pamoate double strength oral suspension (EVICT® DS and LASSIE® DS Liquid Wormer plus VET'S OWN™ DS), when used under proposed conditions of use, are safe and effective for labeled indications.

Generic Labeling:

EVICT® DS:

  1. 2 oz. bottle and carton
  2. 4 oz. bottle and carton
  3. 8 oz. bottle and carton
  4. 16 oz. bottle and package insert

LASSIE® DS:

  1. 2 oz. bottle and carton
  2. 4 oz. bottle, carton and package insert

VET'S OWN™ DS:

  1. 2 oz. bottle and carton
  2. 4 oz. bottle and carton
  3. 8 oz. bottle
  4. 16 oz. bottle and package insert

Pioneer Labeling:

  1. Nemex-2™: 2 oz. bottle, carton and package Insert
  2. D-Worm™ 120: package Insert

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