03-23943. Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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 First Priority, Inc. The ANADA provides for oral use of pyrantel pamoate suspension in horses and ponies for the removal and control of various internal parasites.

DATES:

This rule is effective September 19, 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: [e-mail].

SUPPLEMENTARY INFORMATION:

First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200-353 for PRIMEX (pyrantel pamoate) Equine Anthelmintic Suspension for oral use in horses and ponies for the removal and control of various internal parasites. First Priority's PRIMEX Equine Anthelmintic Suspension is approved as a generic copy of Pfizer, Inc.'s STRONGID T, approved under NADA 91-739. ANADA 200-353 is approved as of August 19, 2003, and the regulations are amended in 21 CFR 520.2043 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 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.

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 congressional review requirements in 5 U.S.C. 801-808.

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: 21 U.S.C. 360b.

§ 520.2043

[Amended]

2. Section 520.2043 Pyrantel pamoate suspension is amended in paragraph (b)(1) by removing “000069” and adding in its place “000069, 058829,”.

Dated: September 11, 2003.

Linda Tollefson,

Deputy Director, Center for Veterinary Medicine.