Document ID: FDA-2012-N-0002-0014
Agency: fda
Document Type: Rule
Title: Conditionally Approved New Animal Drugs for Minor Use and Minor Species Masitinib
Posted Date: 2012-06-15T04:00Z

[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Rules and Regulations]
[Page 35837]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14635]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 516

[Docket No. FDA-2012-N-0002]

Conditionally Approved New Animal Drugs for Minor Use and Minor 
Species; Masitinib

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 a conditionally approved supplemental 
application for conditional approval of a new animal drug (CNADA) 
intended for a minor use filed by AB Science. The supplemental CNADA 
provides for a revised indication for masitinib mesylate tablets in 
dogs.

DATES: This rule is effective June 15, 2012.

FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8234, email: 
steven.fleischer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: AB Science, 3 Avenue George V, 75008 Paris, 
France, filed a supplemental CNADA 141-308 for KINAVET-CA1 (masitinib 
mesylate) Tablets for a revised indication for the treatment of 
nonresectable Grade II or III cutaneous mast cell tumors in dogs that 
have not previously received radiotherapy and/or chemotherapy except 
corticosteroids. In accordance with the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), as amended by the Minor Use and Minor 
Species Animal Health Act of 2004 (MUMS Act), this supplemental 
application is conditionally approved as of January 30, 2012, and the 
regulations in 21 CFR part 516 are amended to reflect this action.
    A summary of safety and effectiveness data and information 
submitted to support conditional 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.
    KINAVET-CA1 (masitinib mesylate) Tablets for the intended uses 
conditionally approved by FDA under application number 141-308 
qualifies for 7 years of exclusive marketing rights beginning on 
December 15, 2010, the date of the original conditional approval. This 
new animal drug qualifies for exclusive marketing rights under section 
573(c) of the FD&C Act (21 U.S.C. 360ccc-2(c)) because it has been 
declared a designated new animal drug by FDA under section 573(a) of 
the FD&C Act.
    FDA 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 in 21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 516 is 
amended as follows:

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
1. The authority citation for 21 CFR part 516 continues to read as 
follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

0
2. In Sec.  516.1318, revise paragraph (c)(2) to read as follows:

Sec.  516.1318  Masitinib.

* * * * *
    (c) * * *
    (2) Indications for use. For the treatment of nonresectable Grade 
II or III cutaneous mast cell tumors in dogs that have not previously 
received radiotherapy and/or chemotherapy except corticosteroids.
* * * * *

    Dated: June 8, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2012-14635 Filed 6-14-12; 8:45 am]
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