Food and Drug Administration, HHS.
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.
This rule is effective December 20, 2010.Start Further Info
FOR FURTHER INFORMATION CONTACT:
John K. Harshman, Center for Veterinary Start Printed Page 79296Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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.Start List of Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
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:Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
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:End Amendment Part
(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 DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. In paragraph (b) of § 524.1465, remove “Nos. 000069 and 025463” and in its place add “Nos. 000069, 025463, and 051672”.End Amendment Part Start Signature
Dated: December 10, 2010.
Director, Center for Veterinary Medicine.
[FR Doc. 2010-31870 Filed 12-17-10; 8:45 am]
BILLING CODE 4160-01-P