2010-31870. New Animal Drugs; Mupirocin

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 Taro Pharmaceuticals U.S.A., Inc. The ANADA provides for veterinary prescription use of mupirocin ointment for the treatment of bacterial skin infections in dogs.

DATES:

This rule is effective December 20, 2010.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532, filed ANADA 200-457 that provides for veterinary prescription use of Mupirocin Ointment USP, 2% for the treatment of bacterial skin infections in dogs. Taro Pharmaceuticals U.S.A., Inc.'s Mupirocin Ointment USP, 2% is approved as a generic copy of Pfizer, Inc.'s BACTODERM Ointment approved under NADA 140-839. The ANADA is approved as of November 29, 2010, and the regulations are amended in 21 CFR 524.1465 to reflect the approval.

In addition, Taro Pharmaceuticals U.S.A., Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. Accordingly, the tables in 21 CFR 510.600(c) are being amended to add entries for this firm.

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.

The Agency has determined under 21 CFR 25.33 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

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 524

• 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 parts 510 and 524 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. In § 510.600, in the table in paragraph (c)(1) alphabetically add an entry for “Taro Pharmaceuticals U.S.A., Inc.”; and in the table in paragraph (c)(2) numerically add an entry for “051672” to read as follows:

§ 510.600

Names, addresses, and drug labeler codes of sponsors of approved applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*    *    *    *    *
Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532	051672
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
051672	Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532.
*    *    *    *    *

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 524 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 524.1465

[Amended]

4. In paragraph (b) of § 524.1465, remove “Nos. 000069 and 025463” and in its place add “Nos. 000069, 025463, and 051672”.

Dated: December 10, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.