Genta files new drug application for FDA approval of Genasense® Plus chemotherapy
Genta Incorporated announced that the Company has completed the filing of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead anticancer drug, Genasense® (oblimersen sodium) Injection. The application proposes the use of Genasense plus fludarabine and cyclophosphamide as treatment for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The NDA was submitted pursuant to FDA's "Fast Track" and "Accelerated Approval" designations. Assuming this application is designated for Priority Review, an approval action would normally occur within six months from the filing date.
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