[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Conditional Approval of a New Animal Drug No Longer In Effect;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ACTION: Notice of conditional approval no longer in effect.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tablets, a new animal drug for a minor use, is no longer in effect.
DATES: Conditional approval is no longer in effect as of December 15,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the FD&C Act (21 U.S.C. 360ccc(h)) the conditional approval is no
longer in effect.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]
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