Genasense
Generic name: oblimersen sodium
Treatment for: Chronic Lymphocytic Leukemia
Genta 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.
Posted: May 2004
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- FDA Advisory Committee Reviews Genasense For Use in Advanced Melanoma - May 3, 2004
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Genasense (oblimersen sodium) FDA Approval History
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