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Notice of Approval of Original Abbreviated New Animal Drug Application; Pyrantel Pamoate Suspension

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: December 4, 2006 (Volume 71, Number 232)]
[Notices]
[Page 70412-70413]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de06-69]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Notice of Approval of Original Abbreviated New Animal Drug
Application; Pyrantel Pamoate Suspension

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice
that it has approved an original abbreviated new animal drug

[[Page 70413]]

application (ANADA) filed by First Priority, Inc. The ANADA provides
for oral use of pyrantel pamoate suspension in horses and ponies as an
over-the-counter (OTC) animal drug product for the removal and control
of various internal parasites.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed ANADA 200-445 providing for oral use of PRIMEX
(pyrantel pamoate) Horse Wormer in horses and ponies as an OTC animal
drug product for the removal and control of various internal parasites.
First Priority, Inc.'s, PRIMEX Horse Wormer is approved as a generic
copy of Pfizer, Inc.'s, PAMOBAN Horse Wormer, approved under NADA 91-
739. In accordance with section 512(i) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360b(i)) and part 514 (21 CFR part
514), in Sec. Sec.  514.105(a) and 514.106(a), the Center for
Veterinary Medicine is providing notice that this ANADA is approved as
of November 3, 2006. 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 Division of Dockets Management
(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.
    FDA 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.

    Dated: November 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-20399 Filed 11-01-06; 8:45 am]
BILLING CODE 4160-01-S

 
 

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