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BMS' teniposide

Executive Summary

Will be reviewed by FDA's Oncologic Drugs Advisory Committee at its July 1-2 meeting at FDA's Parklawn Building in conference rooms D & E. Teniposide's NDA for treatment of refractory childhood acute lymphocytic leukemia was filed in September 1990. Teniposide was approved as a Treatment IND/Group C drug in October 1988 for use in combination with the cancer drug cytarabine to treat refractory lymphoblastic leukemia. Teniposide was licensed from Sandoz, and is marketed worldwide by BMS, except in French territories, under the tradename Vumon.
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PS019099

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