U.S. Bioscience's Ethyol
FDA has responded to the August 1993 amendment to U.S. Bioscience's NDA for the chemo-radiotherapy protective agent Ethyol (amifostine), indicating that it will require additional analyses and data from a pivotal ovarian cancer trial and other information, the West Conshohocken, Penn. company announces Dec. 20. U.S. Bioscience plans to "seek clarification" from FDA and provide additional information. The company recently has completed its response to the list of questions posed by the European Committee on Proprietary Medicinal Products
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