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Strategies & Market Trends : YEEHAW CANDIDATES

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To: Jibacoa who wrote (15789)3/1/2006 8:34:01 AM
From: Galirayo  Read Replies (1) of 23958
 
[GNTA] Genasense(R) New Drug Application Accepted for Review by FDA
Wednesday March 1, 8:00 am ET
NDA Proposes Use of Genasense plus Chemotherapy for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

biz.yahoo.com

BERKELEY HEIGHTS, N.J., March 1 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for Genasense® (oblimersen sodium) Injection. The NDA proposes the use of Genasense plus fludarabine and cyclophosphamide for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The filing was granted an action date by FDA under the Prescription Drug User Fee Act (PDUFA) of October 28, 2006.
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"This filing represents the first NDA for a drug that promotes chemotherapy-induced apoptosis in hematologic oncology," said Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "We plan to work closely with FDA as we seek approval to commercialize this new treatment option for patients with advanced CLL."
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