Conditional Approval of a New Animal Drug No Longer In Effect; Masitinib Mesylate Tablets, 3432 [2016-01104]
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Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
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Jill Hartzler Warner,
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[FR Doc. 2016–01165 Filed 1–20–16; 8:45 am]
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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Drug No Longer In Effect; Masitinib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.
Notice of conditional approval
no longer in effect.
ACTION:
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use, is no longer in effect.
DATES: Conditional approval is no
longer in effect as of December 15, 2015.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, herman.schoenemann@
fda.hhs.gov.
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
asabaliauskas on DSK9F6TC42PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:26 Jan 20, 2016
Jkt 238001
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approval is no longer in effect.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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Food and Drug Administration
[Docket No. FDA–2013–D–0749]
Implanted Blood Access Devices for
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HHS.
ACTION:
Notice of availability.
The Food and Drug
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E:\FR\FM\21JAN1.SGM
21JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
herman.schoenemann@fda.hhs.gov.
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
