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Center | Date | Time | Location |
---|---|---|---|
CDER | May 17, 2006 | 8:00 a.m. - 5:00 p.m. | Hilton Washington
D.C. North |
Agenda:
The committee will discuss supplemental new drug application (NDA) 20823, SE1-016,
EXELON (rivastigmine tartrate) Capsules (1.5 milligrams (mg), 3.0 mg, 4.5 mg,
and 6.0 mg), Novartis Pharmaceuticals Corporation, for the proposed indication
of the treatment of mild to moderate dementia associated with Parkinson's disease.
Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading).
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 May 3, 2006. 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 May 3, 2006, 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 Darrell Lyons at least 7 days in advance of the meeting.
Contact Person:
Darrell Lyons, 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, e-mail: Lyonsd@cder.fda.gov
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this
meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512543.