05-24440. Oral Dosage Form New Animal Drugs; Furosemide

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 furosemide syrup for the treatment of edema in dogs.

DATES:

This rule is effective December 27, 2005.

FOR FURTHER INFORMATION CONTACT:

Linda M. Wilmot, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-1069, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200-373 for Furosemide Syrup 1% for oral use in dogs for the treatment of edema. First Priority, Inc.'s, Furosemide Syrup 1% is approved as a generic copy of Intervet, Inc.'s, LASIX (furosemide) Syrup 1%, approved under NADA 102-380. ANADA 200-373 is approved as of November 18, 2005, and the regulations are amended in 21 CFR 520.1010 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.

§ 520.1010

[Amended]

2. Section 520.1010 is amended in paragraph (b)(3) by removing “No. 059130” and by adding in its place “Nos. 058829 and 059130”.

Dated: December 12, 2005.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.