Determination That MESANTOIN (Mephenytoin) Tablets, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 63405-63406 [E9-28872]
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jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 231 / Thursday, December 3, 2009 / Notices
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg, are the subject of approved NDA
21–729 held by Otsuka Pharmaceutical
Company, Limited (Otsuka). ABILIFY
(aripiprazole) is indicated for the
treatment of schizophrenia, for the acute
and maintenance treatment of manic
and mixed episodes associated with
bipolar I disorder, as an adjunctive
therapy to either lithium or valproate for
the acute treatment of manic and mixed
episodes associated with bipolar I
disorder, for use as an adjunctive
therapy to antidepressants for the
treatment of major depressive disorder,
for the treatment of irritability
associated with autistic disorder, and
for the acute treatment of agitation
associated with schizophrenia or bipolar
I disorder, manic or mixed.
FDA approved the NDA for ABILIFY
DISCMELT (aripiprazole) orally
disintegrating tablets, including the 20mg and 30-mg strengths, on June 7,
2006. Otsuka has never marketed the 20mg and 30-mg strengths of ABILIFY
DISCMELT (aripiprazole) orally
disintegrating tablets, and the 20-mg
and 30-mg strength orally disintegrating
tablets are listed in the ‘‘Discontinued
Drug Product List’’ of the Orange Book.
Rakoczy Molino Mazzochi Siwik LLP
submitted a citizen petition dated May
29, 2008 (Docket No. FDA–2008–P–
0330), under 21 CFR 10.30, requesting
that the agency (1) determine that
ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg, were discontinued from sale for
reasons unrelated to safety and efficacy
and (2) accept ANDAs for aripiprazole
orally disintegrating tablets, 20 mg and
30 mg, and determine that such ANDAs
are eligible for approval if all other legal
and regulatory requirements are met.
After considering the citizen petition
and reviewing agency records, FDA has
determined that ABILIFY DISCMELT
(aripiprazole) orally disintegrating
tablets, 20 mg and 30 mg, were not
VerDate Nov<24>2008
16:16 Dec 02, 2009
Jkt 220001
withdrawn from sale for reasons of
safety or effectiveness. To date, Otsuka
has not marketed ABILIFY DISCMELT
(aripiprazole) orally disintegrating
tablets, 20 mg and 30 mg. In previous
instances (see, e.g., 72 FR 9763, March
5, 2007; 61 FR 25497, May 21, 1996), the
agency has determined that, for
purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
The petitioner identified no data or
other information suggesting that
ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg, were withdrawn from sale as a
result of safety or effectiveness
concerns. FDA has reviewed its files for
records concerning the withdrawal of
ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg. There is no indication that
Otsuka’s decision not to market
ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg, commercially is a function of
safety or effectiveness concerns, and no
information has been submitted to the
docket concerning the reason for which
ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg, were withdrawn from sale.
FDA’s independent evaluation of
relevant information has uncovered
nothing that would indicate that
ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg, were withdrawn from sale for
reasons of safety or effectiveness.
For the reasons outlined in this
document, FDA has determined that
ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the agency will continue
to list ABILIFY DISCMELT
(aripiprazole) orally disintegrating
tablets, 20 mg and 30 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to ABILIFY DISCMELT (aripiprazole)
orally disintegrating tablets, 20 mg and
30 mg, may be approved by the agency
as long as they meet all relevant legal
and regulatory requirements for
approval of ANDAs. If FDA determines
that labeling for these drug products
should be revised to meet current
standards, the agency will advise ANDA
applicants to submit such labeling.
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
63405
Dated: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–28871 Filed 12–2–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0560]
Determination That MESANTOIN
(Mephenytoin) Tablets, 100 Milligrams,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that MESANTOIN
(mephenytoin) Tablets, 100 milligrams
(mg), was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for mephenytoin
tablets, 100 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6312,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
E:\FR\FM\03DEN1.SGM
03DEN1
jlentini on DSKJ8SOYB1PROD with NOTICES
63406
Federal Register / Vol. 74, No. 231 / Thursday, December 3, 2009 / Notices
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
Schiff & Co. submitted a citizen
petition dated October 16, 2008 (Docket
No. FDA–2008–P–0560), under 21 CFR
10.30, requesting that the agency
determine whether MESANTOIN
(mephenytoin) Tablets, 100 mg, was
withdrawn from sale for reasons of
safety or effectiveness. MESANTOIN
(mephenytoin) Tablets, 100 mg, is the
subject of NDA 6–008, held by Novartis
and initially approved on October 23,
1946. MESANTOIN is indicated to
control grand mal, local, Jacksonian,
and psychomotor seizures in patients
who have been refractory to less toxic
anticonvulsants. In a letter dated
January 13, 2000, Novartis notified FDA
that MESANTOIN (mephenytoin)
Tablets, 100 mg, was being discontinued
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
FDA has reviewed its records and,
under § 314.161, has determined that
MESANTOIN (mephenytoin) Tablets,
100 mg, was not withdrawn from sale
for reasons of safety or effectiveness.
The petitioner identified no data or
other information suggesting that
MESANTOIN (mephenytoin) Tablets,
100 mg, was withdrawn for reasons of
safety or effectiveness. FDA has
independently evaluated relevant
literature and data for possible
postmarketing adverse events and has
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list
MESANTOIN (mephenytoin) Tablets,
100 mg, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
VerDate Nov<24>2008
16:16 Dec 02, 2009
Jkt 220001
ANDAs that refer to MESANTOIN
(mephenytoin) Tablets, 100 mg, may be
approved by the agency if all other legal
and regulatory requirements for the
approval of ANDAs are met. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the agency will
advise ANDA applicants to submit such
labeling.
Dated: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–28872 Filed 12–2–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2009–0138]
Homeland Security Advisory Council
AGENCY:
The Office of Policy, DHS.
ACTION: Notice of Cancellation of the
Homeland Security Advisory Council
Federal Advisory Committee Meeting.
SUMMARY: The meeting of the Homeland
Security Advisory Council, scheduled
for December 4, 2009 from 3 to 4 p.m.
EST is cancelled. Notice of this meeting
was published in the November 10,
2009 Federal Register (Volume 74,
Number 216) at DHS–2009–0138.
FOR FURTHER INFORMATION CONTACT:
Contact the HSAC staff at 202–447–3135
or hsac@dhs.gov.
The HSAC
provides independent advice to the
Secretary of the Department of
Homeland Security to aide in the
creation and implementation of critical
and actionable policies and capabilities
across the spectrum of homeland
security operations. The HSAC
periodically reports, as requested, to the
Secretary, on such matters. Notice of
cancellation of this meeting is given
under the Federal Advisory Committee
Act (FACA), Public Law 92–463, as
amended, 5 U.S.C. App.
SUPPLEMENTARY INFORMATION:
Dated: November 25, 2009.
Becca Sharp,
Executive Director, Homeland Security
Advisory Committee.
[FR Doc. E9–28861 Filed 12–2–09; 8:45 am]
BILLING CODE 9010–9M–P
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Application-Permit-Special
License Unlading-Lading-Overtime
Services
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30-Day notice and request for
comments; Extension of an existing
information collection: 1651–0005.
SUMMARY: U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act: Application-PermitSpecial License Unlading-LadingOvertime Services (Form 3171). This is
a proposed extension of an information
collection that was previously
approved. CBP is proposing that this
information collection be extended with
no change to the burden hours. This
document is published to obtain
comments from the public and affected
agencies. This proposed information
collection was previously published in
the Federal Register (74 FR 50811) on
October 1, 2009, allowing for a 60-day
comment period. This notice allows for
an additional 30 days for public
comments. This process is conducted in
accordance with 5 CFR 1320.10.
DATES: Written comments should be
received on or before January 4, 2010.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–5806.
SUPPLEMENTARY INFORMATION: U.S.
Customs and Border Protection (CBP)
encourages the general public and
affected Federal agencies to submit
written comments and suggestions on
proposed and/or continuing information
collection requests pursuant to the
Paperwork Reduction Act (Pub. L. 104–
13). Your comments should address one
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 74, Number 231 (Thursday, December 3, 2009)]
[Notices]
[Pages 63405-63406]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28872]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0560]
Determination That MESANTOIN (Mephenytoin) Tablets, 100
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
determination that MESANTOIN (mephenytoin) Tablets, 100 milligrams
(mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for mephenytoin tablets, 100 mg, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs.
[[Page 63406]]
FDA publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which is known generally as the
``Orange Book.'' Under FDA regulations, drugs are removed from the list
if the agency withdraws or suspends approval of the drug's NDA or ANDA
for reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162). Under Sec. 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must determine whether a listed drug was
withdrawn from sale for reasons of safety or effectiveness before an
ANDA that refers to that listed drug may be approved. FDA may not
approve an ANDA that does not refer to a listed drug.
Schiff & Co. submitted a citizen petition dated October 16, 2008
(Docket No. FDA-2008-P-0560), under 21 CFR 10.30, requesting that the
agency determine whether MESANTOIN (mephenytoin) Tablets, 100 mg, was
withdrawn from sale for reasons of safety or effectiveness. MESANTOIN
(mephenytoin) Tablets, 100 mg, is the subject of NDA 6-008, held by
Novartis and initially approved on October 23, 1946. MESANTOIN is
indicated to control grand mal, local, Jacksonian, and psychomotor
seizures in patients who have been refractory to less toxic
anticonvulsants. In a letter dated January 13, 2000, Novartis notified
FDA that MESANTOIN (mephenytoin) Tablets, 100 mg, was being
discontinued and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
FDA has reviewed its records and, under Sec. 314.161, has
determined that MESANTOIN (mephenytoin) Tablets, 100 mg, was not
withdrawn from sale for reasons of safety or effectiveness. The
petitioner identified no data or other information suggesting that
MESANTOIN (mephenytoin) Tablets, 100 mg, was withdrawn for reasons of
safety or effectiveness. FDA has independently evaluated relevant
literature and data for possible postmarketing adverse events and has
found no information that would indicate that this product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list MESANTOIN (mephenytoin)
Tablets, 100 mg, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to MESANTOIN (mephenytoin) Tablets, 100 mg, may be approved by
the agency if all other legal and regulatory requirements for the
approval of ANDAs are met. If FDA determines that labeling for this
drug product should be revised to meet current standards, the agency
will advise ANDA applicants to submit such labeling.
Dated: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28872 Filed 12-2-09; 8:45 am]
BILLING CODE 4160-01-S
