Determination That LAMICTAL (Lamotrigine) Tablets, 50 Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 9763-9764 [E7-3713]
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Federal Register / Vol. 72, No. 42 / Monday, March 5, 2007 / Notices
Place: John M. Eisenberg Building, AHRQ
Conference Center, 540 Gaither Road,
Rockville, Maryland 20850.
Contact Person: Anyone wishing to obtain
a roster of members, agenda or minutes of the
non-confidential portions of this meeting
should contact Mrs. Bonnie Campbell,
Committee Management Officer, Office of
Extramural Research, Education and Priority
Populations, AHRQ, 540 Gaither Road, Room
2038, Rockville, Maryland 20850, Telephone
(301) 427–1554.
Agenda items for this meeting are subject
to change as priorities dictate.
Dated: February 20, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–978 Filed 3–2–07; 8:45 am]
Dated: February 20, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–979 Filed 3–2–07; 8:45 am]
BILLING CODE 4160–90–M
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Food and Drug Administration
Notice of Meeting
erjones on PRODPC74 with NOTICES
Place: John M. Eisenberg Building, AHRQ
Conference Center, 540 Gaither Road,
Rockville, Maryland 20850.
Contact Person: Anyone wishing to obtain
a roster of members, agenda or minutes of the
non-confidential portions of this meeting
should contact Mrs. Bonnie Campbell,
Committee Management Officer, Office of
Extramural Research, Education and Priority
Populations, AHRQ, 540 Gaither Road, Room
2038, Rockville, Maryland 20850, Telephone
(301) 427–1554.
Agenda items for this meeting are subject
to change as priorities dictate.
Determination That LAMICTAL
(Lamotrigine) Tablets, 50 Milligrams
and 250 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
[Docket No. 2005P–0237]
In accordance with section 10(d) of
the Federal Advisory Committee Act (5
U.S.C., Appendix 2), announcement is
made of a Health Care Policy and
Research Special Emphasis Panel (SEP)
meeting.
A Special Emphasis Panel is a group
of experts in fields related to health care
research who are invited by the Agency
for Healthcare Research and Quality
(AHRQ), and agree to be available, to
conduct on an as needed basis,
scientific reviews of applications for
AHRQ support. Individual members of
the Panel do not attend regularlyscheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
Substantial segments of the upcoming
SEP meeting listed below will be closed
to the public in accordance with the
Federal Advisory Committee Act,
section 10(d) of 5 U.S.C., Appendix 2
and 5 U.S.C. 552b(c)(6). Grant
applications for ‘‘Consumer Assessment
of Healthcare Providers and Systems
(CAHPS)’’ are to be reviewed and
discussed at this meeting. These
discussions are likely to reveal personal
information concerning individuals
associated with the applications. This
information is exempt from mandatory
disclosure under the above-cited
statutes.
SEP Meeting on: Consumer Assessment of
Healthcare Providers and Systems (CAHPS).
Date: March 20, 2007 (Open on March 20
from 9 a.m. to 8:15 a.m. and closed for the
remainder of the meeting).
VerDate Aug<31>2005
16:40 Mar 02, 2007
Jkt 211001
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that LAMICTAL (lamotrigine) tablets, 50
milligrams (mg) and 250 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for lamotrigine
tablets, 50 mg and 250 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
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
sponsors 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 typically a version of the drug
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
9763
that was previously approved. Sponsors
of ANDAs 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.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn 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.
LAMICTAL (lamotrigine) tablets, 50
mg and 250 mg, are the subject of
approved NDA 20–241 held by
GlaxoSmithKline (GSK). LAMICTAL
(lamotrigine) is an antiepileptic drug
indicated as adjunctive therapy for
partial seizures in adults and pediatric
patients. It is also approved for
conversion to monotherapy in adults
with partial seizures who are receiving
treatment with a single enzymeinducing antiepileptic drug or valproate.
In addition, LAMICTAL (lamotrigine) is
indicated for the maintenance treatment
of Bipolar I Disorder in certain patients.
FDA approved the NDA for
LAMICTAL (lamotrigine) tablets,
including the 50 mg and 250 mg
strengths, on December 27, 1994. GSK
has never marketed the 50 mg and 250
mg strengths of LAMICTAL
(lamotrigine) tablets.
In a citizen petition dated June 9,
2005 (Docket No. 2005P–0237/CP1),
submitted under 21 CFR 10.30, J. Mark
Pohl of Pharmaceutical Patent
Attorneys, LLC, requested that the
agency determine whether LAMICTAL
(lamotrigine) tablets, 50 mg and 250 mg,
were withdrawn from sale for reasons of
safety or effectiveness. After considering
the citizen petition and reviewing
agency records, FDA has determined
E:\FR\FM\05MRN1.SGM
05MRN1
9764
Federal Register / Vol. 72, No. 42 / Monday, March 5, 2007 / Notices
erjones on PRODPC74 with NOTICES
that LAMICTAL (lamotrigine) tablets, 50
mg and 250 mg, were not withdrawn
from sale for reasons of safety or
effectiveness. To date, GSK has not
marketed LAMICTAL (lamotrigine)
tablets, 50 mg and 250 mg. In previous
instances (see, e.g., 67 FR 79640,
December 30, 2002 (addressing a
relisting request for Diazepam
Autoinjector)), 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
LAMICTAL (lamotrigine) tablets, 50 mg
and 250 mg, were withdrawn from sale
as a result of safety or effectiveness
concerns. GSK has marketed other
strengths of LAMICTAL (lamotrigine)
tablets: 25 mg, 100 mg, 150 mg, and 200
mg. FDA has reviewed its files for
records concerning the withdrawal of
LAMICTAL (Lamotrigine) tablets, 50 mg
and 250 mg. There is no indication that
GSK’s decision not to market
LAMICTAL (lamotrigine) tablets, 50 mg
and 250 mg, commercially is a function
of safety or effectiveness concerns, and
no information has been submitted to
the docket concerning the reason for
which LAMICTAL (lamotrigine) tablets,
50 mg and 250 mg, were withdrawn
from sale. FDA’s independent
evaluation of relevant information has
uncovered nothing that would indicate
that LAMICTAL (lamotrigine) tablets, 50
mg and 250 mg, were withdrawn from
sale for reasons of safety or
effectiveness.
For the reasons outlined in this
document, FDA has determined that
LAMICTAL (lamotrigine) tablets, 50 mg
and 250 mg, were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the agency
will continue to list LAMICTAL
(lamotrigine) tablets, 50 mg and 250 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 and effectiveness. ANDAs that
refer to LAMICTAL (lamotrigine)
tablets, 50 mg and 250 mg, may be
approved by the agency, as long as they
meet all relevant legal and regulatory
requirements for approval of ANDAs.
Dated: February 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–3713 Filed 3–2–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:17 Mar 02, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Anti-Infective
Drugs Advisory Committee and the
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Anti-Infective
Drugs Advisory Committee and the
Pediatric Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 12, 2007, from 8:30 a.m.
to 5 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Sohail Mosaddegh,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
sohail.mosaddegh@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington DC area), codes 3014512530
or 8732310001. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss
clinical trial designs for products that
seek indications for the prevention and/
or treatment of disease caused by Shiga
toxin-producing bacteria. FDA intends
to make background material available
to the public no later than 1 business
day before the meeting. If FDA is unable
to post the background material on its
Web site prior to the meeting, the
background material will be made
publicly available at the location of the
advisory committee meeting, and the
background material will be posted on
FDA’s Web site after the meeting.
Background material is available at
https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm, click on the year 2007 and
scroll down to the appropriate advisory
committee link.
Procedure: Interested persons may
present data, information, or views,
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orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 29, 2007.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before March 21, 2007. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 22, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Sohail
Mosaddegh at least 7 days in advance of
the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 26, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–3720 Filed 3–2–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0055]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
E:\FR\FM\05MRN1.SGM
05MRN1
]]>Agencies
[Federal Register Volume 72, Number 42 (Monday, March 5, 2007)]
[Notices]
[Pages 9763-9764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3713]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P-0237]
Determination That LAMICTAL (Lamotrigine) Tablets, 50 Milligrams
and 250 Milligrams, Were 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) has determined that
LAMICTAL (lamotrigine) tablets, 50 milligrams (mg) and 250 mg, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for lamotrigine tablets, 50 mg and 250 mg, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
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
sponsors 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
typically a version of the drug that was previously approved. Sponsors
of ANDAs 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. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, drugs are withdrawn 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
(Sec. 314.162 (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.
LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, are the subject
of approved NDA 20-241 held by GlaxoSmithKline (GSK). LAMICTAL
(lamotrigine) is an antiepileptic drug indicated as adjunctive therapy
for partial seizures in adults and pediatric patients. It is also
approved for conversion to monotherapy in adults with partial seizures
who are receiving treatment with a single enzyme-inducing antiepileptic
drug or valproate. In addition, LAMICTAL (lamotrigine) is indicated for
the maintenance treatment of Bipolar I Disorder in certain patients.
FDA approved the NDA for LAMICTAL (lamotrigine) tablets, including
the 50 mg and 250 mg strengths, on December 27, 1994. GSK has never
marketed the 50 mg and 250 mg strengths of LAMICTAL (lamotrigine)
tablets.
In a citizen petition dated June 9, 2005 (Docket No. 2005P-0237/
CP1), submitted under 21 CFR 10.30, J. Mark Pohl of Pharmaceutical
Patent Attorneys, LLC, requested that the agency determine whether
LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were withdrawn from
sale for reasons of safety or effectiveness. After considering the
citizen petition and reviewing agency records, FDA has determined
[[Page 9764]]
that LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were not
withdrawn from sale for reasons of safety or effectiveness. To date,
GSK has not marketed LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg.
In previous instances (see, e.g., 67 FR 79640, December 30, 2002
(addressing a relisting request for Diazepam Autoinjector)), the agency
has determined that, for purposes of Sec. Sec. 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 LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were withdrawn
from sale as a result of safety or effectiveness concerns. GSK has
marketed other strengths of LAMICTAL (lamotrigine) tablets: 25 mg, 100
mg, 150 mg, and 200 mg. FDA has reviewed its files for records
concerning the withdrawal of LAMICTAL (Lamotrigine) tablets, 50 mg and
250 mg. There is no indication that GSK's decision not to market
LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, commercially is a
function of safety or effectiveness concerns, and no information has
been submitted to the docket concerning the reason for which LAMICTAL
(lamotrigine) tablets, 50 mg and 250 mg, were withdrawn from sale.
FDA's independent evaluation of relevant information has uncovered
nothing that would indicate that LAMICTAL (lamotrigine) tablets, 50 mg
and 250 mg, were withdrawn from sale for reasons of safety or
effectiveness.
For the reasons outlined in this document, FDA has determined that
LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, were not withdrawn
from sale for reasons of safety or effectiveness. Accordingly, the
agency will continue to list LAMICTAL (lamotrigine) tablets, 50 mg and
250 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 and effectiveness. ANDAs that refer to
LAMICTAL (lamotrigine) tablets, 50 mg and 250 mg, may be approved by
the agency, as long as they meet all relevant legal and regulatory
requirements for approval of ANDAs.
Dated: February 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3713 Filed 3-2-07; 8:45 am]
BILLING CODE 4160-01-S
