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Monday, 02/27/2012 2:31:07 PM

Monday, February 27, 2012 2:31:07 PM

Post# of 6072
Schedule is out from FDA..

TLON has FDA-ODAC -Meeting for Marqibo approval on 21st March2012

Agenda

The committee will discuss New Drug Application (NDA) 202497, with the proposed trade name Marqibo (vincristine sulfate liposomes injection), application submitted by Talon Therapeutics, Incorporated. The proposed indication (use) for this product is for the treatment of adult patients with Philadelphia Chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of anti-leukemia therapy.

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm290531.htm

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