[Federal Register Volume 61, Number 232 (Monday, December 2, 1996)]
[Rules and Regulations]
[Pages 63711-63712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30653]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520


Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Happy Jack, Inc. The ANADA provides for 
oral use of pyrantel pamoate suspension for removal of large roundworms 
and hookworms in puppies and dogs and to prevent reinfections of 
Toxocara canis in puppies and adult dogs and in lactating bitches after 
whelping.

EFFECTIVE DATE: December 2, 1996.

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1616.

SUPPLEMENTARY INFORMATION: Happy Jack, Inc., P.O. Box 475, Highway 258 
South, Snow Hill, NC 28580, filed ANADA 200-007, which provides for 
oral use of Liqui-Vict 2XTM (pyrantel pamoate) oral suspension for 
removal of large roundworms (T. canis and Toxascaris leonina) and 
hookworms (Ancylostoma caninum and Uncinaria

[[Page 63712]]

stenocephala) in puppies and dogs and to prevent reinfections of T. 
canis in puppies and adult dogs and in lactating bitches after 
whelping. The product contains pyrantel pamoate equivalent to 4.54 
milligrams of pyrantel base.
    Approval of ANADA 200-007 for Happy Jack, Inc.'s, pyrantel pamoate 
suspension is as a generic copy of Pfizer's NADA 100-237 Nemex-2TM 
(pyrantel pamoate). The ANADA is approved as of October 30, 1996, and 
the regulations are amended in 21 CFR 520.2043(b)(2) to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

List of Subjects in 21 CFR Part 520

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:
    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 520.2043 is amended by adding a new sentence at the end 
of paragraph (b)(2) to read as follows:


Sec. 520.2043  Pyrantel pamoate suspension.

 * * * * *
    (b) * * *
    (2) * *  * See No. 023851 for use of 4.54 milligrams per milliliter 
product.
 * * * * *

    Dated: November 22, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-30653 Filed 11-29-96; 8:45 am]
BILLING CODE 4160-01-F