[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Rules and Regulations]
[Pages 37711-37712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18459]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 a supplemental abbreviated new
animal drug application (ANADA) filed by Lambert-Kay, Division of
Carter-Wallace, Inc. The supplemental ANADA provides for oral use 4.54
milligrams per milliliter (mg/mL) pyrantel pamoate suspension in
addition to the 2.27 mg/mL product 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: July 15, 1997.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: Lambert-Kay, Division of Carter-Wallace,
Inc., P.O. Box 1001, Half Acre Rd., Cranbury, NJ 08512-0181, filed a
supplement to ANADA 200-028 that provides for oral use of 4.54 mg/mL of
Evict, Lassie, and Vet's Own (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 supplemental ANADA provides for use of 4.54 mg/mL
pyrantel pamoate suspension in addition to 2.27 mg/mL suspension.
Approval of supplemental ANADA 200-028 for Lambert-Kay's pyrantel
[[Page 37712]]
pamoate suspension is as a generic copy of Pfizer's NADA 100-237 Nemex-
2TM (pyrantel pamoate) suspension. The supplemental ANADA is
approved as of June 4, 1997, 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 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 revising paragraph (b)(2) to read
as follows:
Sec. 520.2043 Pyrantel pamoate suspension.
* * * * *
(b) * * *
(2) Sponsors. See Nos. 000069 and 011615 for use of 2.27 and 4.54
milligrams per milliliter product. See No. 023851 for use of 4.54
milligrams per milliliter product.
* * * * *
Dated: June 20, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-18459 Filed 7-14-97; 8:45 am]
BILLING CODE 4160-01-F
