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U.S. Bioscience’s Ethyol

Executive Summary

Firm submits amendments to its NDA for the chemoprotective drug to FDA, U.S. Bioscience reports Aug. 31. Included in the amendment are results from a trial of 200 patients with advanced ovarian cancer treated with cyclophosphamide and cisplatin, and other additional clinical and preclinical data, the west Conshohocken, Penn.-based company notes. U.S. Bioscience had halted the ovarian cancer patient trial after data on 121 of the 200 proposed patients had been collected and submitted an NDA based on the trial; however, FDA's Oncologic Drugs Advisory Committee recommended in January that the trial be completed.
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PS023313

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