Genasense
oblimersen sodium
Treatment for Chronic Lymphocytic LeukemiaGenta Announces Withdrawal of New Drug Application for Genasense in Melanoma
BERKELEY HEIGHTS, N.J., May 13, 2004 -- Genta Incorporated (NASDAQ:GNTA) today announced that it has notified the U.S. Food and Drug Administration (FDA) of its decision to withdraw a New Drug Application (NDA) for Genasense (oblimersen sodium) Injection. The NDA had been submitted in December 2003 for the use of Genasense plus dacarbazine for the treatment of patients with advanced melanoma. On May 3, 2004, an FDA Advisory Committee voted not to recommend Genasense for marketing approval. Under the Prescription Drug User Fee Act, the time for review of the NDA would have expired on June 8, 2004.
Coincident with the NDA withdrawal, Genta has requested a meeting with the FDA to review key issues and to identify next steps related to further development of Genasense in melanoma.
For further information, please visit www.genta.com
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FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data - March 17, 2008
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Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia - February 6, 2007
Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia - December 15, 2006
FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia - October 30, 2006
Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application - September 5, 2006
Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia - July 27, 2006
Genasense New Drug Application Accepted for Review by FDA - March 1, 2006
Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia - December 29, 2005
Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia - June 30, 2005
FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma - May 3, 2004
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Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma - February 6, 2004
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