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Center | Date | Time | Location |
---|---|---|---|
CDER | March 6, 2006 | 8:30 a.m. - 5:00 p.m. | Food and Drug
Administration |
Agenda:
The committee will discuss new drug application (NDA) 21-572/S-008, Cubicin
(daptomycin for injection 500 mg/vial), Sponsor Cubist Pharmaceuticals, for
the proposed indication of the treatment of staphylococcus aureus bacteremia,
including those with known or suspected endocarditis caused by methicillin-susceptible
and methicillin-resistant strains.
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 February 27, 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 February 27, 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
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please contact Cathy A. Groupe at least 7 days in advance of the meeting.
Contact Person:
Cathy A. Groupe, 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: GroupeC@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 3014512530.