Document ID: FDA-2010-N-0002-0085
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Mupirocin
Posted Date: 2010-12-20T05:00Z

[Federal Register: December 20, 2010 (Volume 75, Number 243)]
[Rules and Regulations]               
[Page 79295-79296]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de10-8]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524

[Docket No. FDA-2010-N-0002]

 
New Animal Drugs; Mupirocin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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

[[Page 79296]]

Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8197, e-mail: john.harshman@fda.hhs.gov.

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

0
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.

0
2. In Sec.  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:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

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

                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
        Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                                * * * * *
051672...........................  Taro Pharmaceuticals U.S.A., Inc., 3
                                    Skyline Dr., Hawthorne, NY 10532.

                                * * * * *
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PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.1465  [Amended]

0
4. In paragraph (b) of Sec.  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.
[FR Doc. 2010-31870 Filed 12-17-10; 8:45 am]
BILLING CODE 4160-01-P