Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting, 9764 [E7-3720]
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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mg and 250 mg, were not withdrawn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and 250 mg, were withdrawn from sale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50 mg and 250 mg, were withdrawn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mg and 250 mg, were withdrawn from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and 250 mg, were not withdrawn from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]
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15:17 Mar 02, 2007
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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,
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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]
BILLING CODE 4160–01–S
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]
[Page 9764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3720]
-----------------------------------------------------------------------
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, 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]
BILLING CODE 4160-01-S
