Document ID: FDA-2011-N-0003-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Masitinib
Posted Date: 2011-02-04T05:00Z

[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Rules and Regulations]
[Pages 6326-6327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2519]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 516

[Docket No. FDA-2011-N-0003]

New Animal Drugs; 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 conditional approval of an application for 
a new animal drug intended for a minor use filed by AB Science. The 
application for conditional approval provides for the veterinary 
prescription use of masitinib mesylate tablets in dogs.

DATES: This rule is effective February 4, 2011.

FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for 
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8322, e-mail: 
lisa.troutman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: AB Science, 3 Avenue George V, 75008 Paris, 
France, filed an application for conditional approval (141-308) that 
provides for veterinary prescription use of KINAVET-CA1 (masitinib 
mesylate) Tablets for the treatment of recurrent (post-surgery) or 
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 drug is 
conditionally approved as of December 15, 2010, and the regulations in 
part 516 (21 CFR part 516) are amended by adding new Sec.  516.1318.
    In addition, AB Science has not been previously listed in the 
animal drug regulations as a sponsor of an approved application. 
Accordingly, 21 CFR 510.600(c) is 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 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.
    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.
    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 the 
date of 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

[[Page 6327]]

been declared a designated new animal drug by FDA under section 573(a) 
of the FD&C Act.
    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 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 parts 510 and 
516 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 ``AB Science''; and in the table in paragraph (c)(2), 
numerically add an entry for ``052913'' 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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                                * * * * *
AB Science, 3 Avenue George V, 75008 Paris, France......          052913
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
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                                * * * * *
052913..............................  AB Science, 3 Avenue George V,
                                       75008 Paris, France.
 
                                * * * * *
------------------------------------------------------------------------

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

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

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

0
4. Add Sec.  516.1318 to subpart E to read as follows:

Sec.  516.1318  Masitinib.

    (a) Specifications. Each tablet contains 50 or 150 milligrams (mg) 
masitinib mesylate.
    (b) Sponsor. See No. 052913 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 12.5 mg/kilograms (5.7 
mg/lb) of body weight daily.
    (2) Indications for use. For the treatment of recurrent (post-
surgery) or nonresectable Grade II or III cutaneous mast cell tumors in 
dogs that have not previously received radiotherapy and/or chemotherapy 
except corticosteroids.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

    Dated: January 28, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-2519 Filed 2-3-11; 8:45 am]
BILLING CODE 4160-01-P