Notice of Meeting, 9763 [07-979]
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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Withdrawn From Sale for Reasons of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
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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
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[Federal Register Volume 72, Number 42 (Monday, March 5, 2007)]
[Notices]
[Page 9763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-979]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Notice of Meeting
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 regularly-
scheduled 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).
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. 07-979 Filed 3-2-07; 8:45 am]
BILLING CODE 4160-90-M
