U.S. Bioscience Inc. said Thursday that it filed for marketingapproval of Ethyol with the European Community's Committeeon Proprietary and Medicinal Products (CPMP) and the healthministries of the individual EC member nations.
As a designated high-technology product, the chemoprotectiveand radioprotective agent qualifies for review under an ECprovision that grants a drug developer 10 years of marketingexclusivity upon marketing approval.
A U.S. FDA advisory committee last February failed torecommend approval of Ethyol as a treatment to protecthealthy cells from chemotherapy. The FDA told U.S. Biosciencelast May that additional data could provide the basis for anapprovable indication. The company said Thursday it hasaccrued 185 of the 200 patients needed for the study.
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