E7-7472. Oral Dosage Form New Animal Drugs; Clindamycin Solution

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 the veterinary prescription use of clindamycin hydrochloride oral solution in dogs and cats for the treatment of various infections due to susceptible bacterial pathogens.

DATES:

This rule is effective April 20, 2007.

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 200-398 for the veterinary prescription use of Clindamycin Hydrochloride Oral Drops in dogs and cats for the treatment of various infections due to susceptible bacterial pathogens. First Priority, Inc.'s Clindamycin Hydrochloride Oral Drops is approved as a generic copy of ANTIROBE AQUADROPS Liquid, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 135-940. The ANADA is approved as of March 19, 2007, and 21 CFR 520.447 is amended to reflect the approval.

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 the 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.

2. In § 520.447 revise paragraph (b) to read as follows:

§ 520.447

Clindamycin Solution.

(b) Sponsors. See Nos. 000009, 051311, 058829, and 059130 in § 510.600(c) of this chapter.

Dated: April 9, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.