[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
