Genasense
Generic name: oblimersen sodium
Treatment for: Chronic Lymphocytic Leukemia
Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia
BERKELEY HEIGHTS, N.J., July 27, 2006 -- Genta Incorporated announced that the Company has been notified by the Food and Drug Administration (FDA) that the Oncology Drug Advisory Committee (ODAC) will review the New Drug Application (NDA) for Genasense (oblimersen sodium) Injection plus chemotherapy for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) on September 6, 2006. The NDA has a target action date for a marketing approval decision by October 29, 2006 under the Prescription Drug User Fee Act (PDUFA).
"We are very pleased to have this opportunity to present the Genasense data in CLL to the ODAC," commented Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "This event represents the next key step in the approval process for Genasense, and we look forward to reviewing our application with the FDA advisors."
Posted: July 2006
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- Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia - December 12, 2008
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- FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data - March 17, 2008
- FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia - January 14, 2008
- Genta Completes Appeal of FDA Decision for Genasense in CLL - October 25, 2007
- Genta Appeals FDA Decision on Genasense in CLL - April 4, 2007
- 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
- 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
- Genta Announces Withdrawal of New Drug Application for Genasense in Melanoma - May 13, 2004
- FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma - May 3, 2004
- Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma - April 20, 2004
- Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma - February 6, 2004
Genasense (oblimersen sodium) FDA Approval History
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