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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