[Federal Register Volume 68, Number 111 (Tuesday, June 10, 2003)]
[Rules and Regulations]
[Page 34533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14546]


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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 Paste

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 Cross Vetpharm Group, Ltd. The ANADA 
provides for the oral use of pyrantel pamoate paste for the removal and 
control of certain internal parasites in horses and ponies.

DATES: This rule is effective June 10, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group, Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-350 that provides for the 
use of EXODUS (pyrantel pamoate) Paste for the removal and control of 
certain internal parasites in horses and ponies. Cross Vetpharm Group 
Ltd.'s EXODUS Paste is approved as a generic copy of Pfizer, Inc.'s 
STRONGID (pyrantel pamoate) Paste approved under NADA 129-831. The 
ANADA is approved as of March 25, 2003, and the regulations are amended 
in 21 CFR 520.2044 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, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

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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

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

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2. Section 520.2044 is amended by adding paragraphs (a)(3) and (b)(3) 
to read as follows:


Sec.  520.2044  Pyrantel pamoate paste.

    (a) * * *
    (3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate).
    (b) * * *
    (3) No. 061623 for use of product described in paragraph (a)(3) of 
this section.
* * * * *

    Dated: May 27, 2003.
Steven F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-14546 Filed 6-9-03; 8:45 am]
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