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Aventis, Genta To Meet With FDA After Genasense NDA Withdrawal

Executive Summary

Aventis will participate in Genta's meeting with FDA following the withdrawal of the new drug application for Genasense

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Genta's chronic lymphocytic leukemia treatment Genasense will be reviewed by FDA's Oncologic Drugs Advisory Committee Sept. 6, the company said. The oblimersen injection plus chemotherapy regimen is currently pending at FDA under a standard review, with an Oct. 29 user fee date. Genta initially sought a melanoma indication, but withdrew the NDA in May 2004 following a negative advisory committee review (1"The Pink Sheet" May 24, 2004, p. 12)...

Genasense AC review

Genta's chronic lymphocytic leukemia treatment Genasense will be reviewed by FDA's Oncologic Drugs Advisory Committee Sept. 6, the company said. The oblimersen injection plus chemotherapy regimen is currently pending at FDA under a standard review, with an Oct. 29 user fee date. Genta initially sought a melanoma indication, but withdrew the NDA in May 2004 following a negative advisory committee review (1"The Pink Sheet" May 24, 2004, p. 12)...

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