E6-20399. Notice of Approval of Original Abbreviated New Animal Drug Application; Pyrantel Pamoate Suspension

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is providing notice that it has approved an original abbreviated new animal drug 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: [e-mail].

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 §§ 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.