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U.S. Centers for Disease Control and Prevention • Medical News
Schering-Plough Drug Gets Fast Track

January 31, 2006

Schering-Plough said Monday that the Food and Drug Administration had given fast track status to its experimental hepatitis C drug SCH 503034. The medication is now in mid-stage human trials as an oral treatment for chronic hepatitis C infection. Fast track status allows the manufacturer to submit data as they become available, instead of all at once, and it gives a formal framework for discussions with FDA during the review period. The target patients for the new drug, FDA said, are those with a specific hepatitis C genotype 1 strain who have failed on standard treatments.

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Excerpted from:
Associated Press
01.30.06


This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.