Genasense FDA Approval Status
FDA Approved: No
Brand name: Genasense
Generic name: oblimersen sodium
Company: Genta Incorporated
Treatment for: Chronic Lymphocytic Leukemia
Genasense (oblimersen sodium) is a Bcl-2 antisense oligonucleotide intended for use in the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
In December 2008, Genta Incorporated announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Genasense had not been approved.
Development timeline for Genasense
Date | Article |
---|
Mar 9, 2009 | FDA Appeal Decision Indicates that Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial |
Dec 12, 2008 | Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia |
Dec 3, 2008 | Genta Receives Complete Response Letter from FDA to Amended Application of Genasense in Patients with Chronic Lymphocytic Leukemia |
Jul 14, 2008 | FDA Accepts Genta's NDA Amendment as Complete Response for
Genasense Treatment of Chronic Lymphocytic Leukemia |
Jun 6, 2008 | Genta Submits NDA Amendment to FDA for Genasense as Treatment of
Chronic Lymphocytic Leukemia |
Mar 17, 2008 | FDA Indicates That Genasense Approval in Chronic Lymphocytic
Leukemia Will Require Additional Confirmatory Data |
Jan 14, 2008 | FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic
Leukemia |
Oct 25, 2007 | Genta Completes Appeal of FDA Decision for Genasense in CLL |
Apr 4, 2007 | Genta Appeals FDA Decision on Genasense in CLL |
Feb 6, 2007 | Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia |
Dec 15, 2006 | Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia |
Oct 30, 2006 | FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia |
Sep 5, 2006 | Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application |
Jul 27, 2006 | Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia |
Mar 1, 2006 | Genasense New Drug Application Accepted for Review by FDA |
Dec 29, 2005 | Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia |
Jun 30, 2005 | Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia |
May 13, 2004 | Genta Announces Withdrawal of New Drug Application for Genasense in Melanoma |
May 3, 2004 | FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma |
Apr 20, 2004 | Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma |
Feb 6, 2004 | Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma |
Further information
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