[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Rules and Regulations]
[Page 35837]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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]
BILLING CODE 4160-01-P