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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-248 Pyrantel Pamoate Suspension - 4.54mg, Pyrantel Pamoate Suspension - 2.27mg - original approval

Approval Date: July 16, 1998

I. GENERAL INFORMATION:

NADA200-248
Sponsor:Phoenix Scientific, Inc.
 
Generic Name:Pyrantel Pamoate USP
Trade Name:Pyrantel Pamoate Suspension - 4.54mg, Pyrantel Pamoate Suspension - 2.27mg
Marketing Status: 

Dosage Form: Oral Suspension

How Supplied: 2 oz and 16 oz HDPE bottles

How Dispensed: OTC

Amount of Active Ingredients: Each mL contains: 4.54 mg Pyrantel (base) as Pyrantel Pamoate 2.27mg Pyrantel (base) as Pyrantel Pamoate

Route of Administration: Oral

Species: Puppies and Dogs (ONLY )

Indications for Use: To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping. For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies. The presence of these parasites should be confirmed by laboratory fecal examination.

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

Labeled Dosage: 4.54 mg/mL

For maximum control and prevention of reinfection, it is recommended that puppies be treated at 2,3,4,6,8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent T.canis reinfection. Administer one full teaspoonful (5mL) for each 10 lb of body weight.

Labeled Dosage: 4.54 mg/mL

For the removal of large roundworms (ascarids) and hookworms. Administer one full teaspoonful (5mL) for each 10 lb of body weight. It is not necessary to withhold food prior to treatment. Dogs usually find this wormer very palatable and will lick the dose from the bowl willingly. If there is reluctance to accept the dose, mix in a small quantity of dog food to encourage consumption.

It is recommended that dogs maintained under conditions of constant exposure to worm infection should have a follow-up fecal exam within 2 to 4 weeks after first treatment.

Labeled Dosage: 2.27 mg/mL

For maximum control and prevention of reinfection, it is recommended that puppies be treated at 2,3,4,6,8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent T.canis reinfection. Administer one full teaspoonful (5mL) for each 5 lb of body weight.

For the removal of large roundworms (ascarids) and hookworms. Administer one full teaspoonful (5mL) for each 5 lb of body weight. It is not necessary to withhold food prior to treatment. Dogs usually find this wormer very palatable and will lick the dose from the bowl willingly. If there is reluctance to accept the dose, mix in a small quantity of dog food to encourage consumption.

It is recommended that dogs maintained under conditions of constant exposure to worm infection should have a follow-up fecal exam within 2 to 4 weeks after first treatment.

 

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. Approval of an ANADA requires that the sponsor show 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 (Fifth GADPTRA Policy Letter, 55 FR 24645, June18,1990; Bioequivalence Guidance, 1996, 61 FR 26182, May 24, 1996).

Based on the formulation characteristics of the generic product, Phoenix Scientific Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product Pyrantel Pamoate Oral Suspension. The generic product is administered as an oral suspension and contains the same active and inactive ingredients in the same concentration as the pioneer product.

 

III. 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.

 

IV. AGENCY CONCLUSION:

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 Pyrantel Pamoate Suspension when used under its proposed conditions of use, is safe and effective for the labeled indications.

Attachment:

  • Generic and pioneer labeling