Genasense
oblimersen sodium
Treatment for Chronic Lymphocytic LeukemiaBriefing Documents Posted for FDA Committee Review of Genasense New Drug Application
BERKELEY HEIGHTS, N.J., September 5, 2006 -- Genta Incorporated announced today that the Food and Drug Administration (FDA) has made public the briefing documents for the Oncology Drug Advisory Committee's (ODAC) review of the New Drug Application (NDA) for Genasense (oblimersen sodium) Injection plus chemotherapy for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia. The ODAC meeting will discuss the Genasense application on September 6, 2006 beginning at 8:00 a.m. EDT.
The documents can be accessed at the Center for Drug Evaluation & Research section of the FDA's website using the following link: http://www.fda.gov/ohrms/dockets/ac/cder06.html#OncologicDrugs.
Source: Genta
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