US Bioscience Amends Ethyol NDA

24 July 1994

US Bioscience has amended its New Drug Application for Ethyol (amifostine) in response to questions raised by the US Food and Drug Administration in December of last year.

The amendment includes further analysis and an update of the completed pivotal trial in ovarian cancer. The company, which is seeking an approval for Ethyol as a chemoprotective agent, was informed by the FDA that it needed more definitive survival data. USB said that the trial results released in May showed that the agent does not adversely affect survival.

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