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Genasense 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 Status and FDA Approval Process for Genasense

DateArticle
Mar  9, 2009FDA Appeal Decision Indicates that Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial
Dec 12, 2008Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia
Dec  3, 2008Genta Receives Complete Response Letter from FDA to Amended Application of Genasense in Patients with Chronic Lymphocytic Leukemia
Jul 14, 2008FDA Accepts Genta's NDA Amendment as Complete Response for Genasense Treatment of Chronic Lymphocytic Leukemia
Jun  6, 2008Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic Leukemia
Mar 17, 2008FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
Jan 14, 2008FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia
Oct 25, 2007Genta Completes Appeal of FDA Decision for Genasense in CLL
Apr  4, 2007Genta Appeals FDA Decision on Genasense in CLL
Feb  6, 2007Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia
Dec 15, 2006Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia
Oct 30, 2006FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia
Sep  5, 2006Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application
Jul 27, 2006Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia
Mar  1, 2006Genasense New Drug Application Accepted for Review by FDA
Dec 29, 2005Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia
Jun 30, 2005Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
May 13, 2004Genta Announces Withdrawal of New Drug Application for Genasense in Melanoma
May  3, 2004FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma
Apr 20, 2004Genta and Aventis Announce Genasense Expanded Access Program for Patients with Advanced Melanoma
Feb  6, 2004Aventis and Genta Announce FDA Acceptance and Priority Review of New Drug Application for Genasense in Advanced Melanoma

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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