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Center | Date | Time | Location |
---|---|---|---|
CDER | September 10, 2004 | 8:30 a.m. - 5 p.m. | Holiday Inn |
Agenda:
The committee will discuss new drug application (NDA) 21–686 proposed
trade name EXANTA (ximelagatran) 24-milligram (mg) and 36-mg tablets, AstraZeneca,
for the proposed indication of the prevention of venous thromboembolism (VTE)
in patients undergoing knee replacement surgery, the prevention of stroke, and
other thromboembolic complications associated with atrial fibrillation and the
long term secondary prevention of VTE after standard treatment of an episode
of acute VTE.
Background material and meeting information will become available no later than one business day before the meeting (Simply select the appropriate 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 by September 2, 2004. Oral presentations from the public will
be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before September 2, 2004, 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. 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 Dornette Spell-LeSane at least 7 days in advance of the meeting.
Contact Person:
Dornette Spell-LeSane, 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: spelllesaned@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512533. Please call the Information Line
for up-to-date information on this meeting.
[ Full FR Notice ]