[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Page 29477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14647]
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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 Lambert-Kay, Div. of Carter-Wallace, 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: June 11, 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: Lambert-Kay, Div. of Carter-Wallace, Inc.,
P.O. Box 1001, Half Acre Rd., Cranbury, NJ 08512-0181, filed ANADA 200-
028, which provides for oral use of Evict, Lassie,
and Vet's OwnTM (pyrantel pamoate) liquid wormer for removal of
large roundworms (T. canis and Toxascaris leonina) and hookworms
(Ancylostoma caninum and Uncinaria 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 2.27 milligrams of pyrantel base.
Approval of ANADA 200-028 for Lambert-Kay's pyrantel pamoate
suspension is as a generic copy of Pfizer's NADA 100-237 NemexTM
(pyrantel pamoate). The ANADA is approved as of March 28, 1996, and the
regulations in 21 CFR 520.2043(b)(2) are amended 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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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 revising paragraph (b)(2) to read
as follows:
Sec. 520.2043 Pyrantel pamoate suspension.
* * * * *
(b) * * *
(2) Sponsors. See No. 000069 for use of 2.27 and 4.54 milligrams
per milliliter product. See No. 011615 for use of 2.27 milligrams per
milliliter product.
* * * * *
Dated: May 15, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-14647 Filed 6-10-96; 8:45 am]
BILLING CODE 4160-01-F
