[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Page 3432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0002]


Conditional Approval of a New Animal Drug No Longer In Effect; 
Masitinib Mesylate Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of conditional approval no longer in effect.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice 
that the conditional approval of an application for masitinib mesylate 
tablets, a new animal drug for a minor use, is no longer in effect.

DATES: Conditional approval is no longer in effect as of December 15, 
2015.

FOR FURTHER INFORMATION CONTACT: Herman M. Schoenemann III, Center for 
Veterinary Medicine (HFV-108), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0652, 
[email protected].

SUPPLEMENTARY INFORMATION: The Federal Food, Drug, and Cosmetic Act 
(FD&C Act), as amended by the Minor Use and Minor Species Animal Health 
Act of 2004 (Pub. L. 108-282), permits conditional approval of new 
animal drugs for minor uses. Conditional approval of a new animal drug 
is effective for a 1-year period, and may be renewed for up to four 
additional 1-year periods. The holder of a conditionally approved new 
animal drug is required to submit all information necessary to support 
a complete new animal drug application (NADA) under section 512(b)(1) 
of the FD&C Act (21 U.S.C. 360b(b)(1) by 180 days before the 
termination of the fifth 1-year period of conditional approval. If FDA 
does not approve an NADA for the new animal drug by the termination 
date of the conditional approval, then pursuant to section 571(h) of 
the FD&C Act (21 U.S.C. 360ccc(h)) the conditional approval is no 
longer in effect.
    AB Science, 3 Avenue George V, 75008 Paris, France, filed an 
application for conditional approval (141-308) that provided 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. That 
application was conditionally approved on December 15, 2010.
    On December 15, 2014, application 141-308 received the fourth and 
final renewal of its conditional approval. That final renewal 
terminated on December 15, 2015. As of that date, FDA did not approve 
an NADA for KINAVET-CA1 under section 512 of the FD&C Act. 
Consequently, as of December 15, 2015, the conditional approval of 
application 141-308 is no longer in effect.
    Because the conditional approval is no longer in effect, KINAVET-
CA1 Tablets is now an unapproved new animal drug product with no legal 
marketing status. Further marketing, sales, and distribution of the 
product are illegal.
    This notice is issued under section 571 of the FD&C Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect that the conditional approval of 
an application for this new animal drug is no longer in effect.

    Dated: January 14, 2016.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2016-01104 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P