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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. Back to other news for January 31, 2006 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. |