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Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Published on April 28, 2010 at 12:47 AM · No Comments

Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the Company has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission.

Following the pre-NDA meeting, Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.

SOURCE Hana Biosciences, Inc.

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Posted in: Medical Condition News | Pharmaceutical News

Tags: Acute Lymphoblastic Leukemia, Cancer, Chemotherapy, Chromosome, Hodgkin's Disease, Hodgkin's Lymphoma, Leukemia, Lymphoma, Melanoma, New Drug Application, Non-Hodgkin's Lymphoma, Vincristine

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