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Pegasys user fee goal

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Roche is granted priority review status for its combination therapy of Pegasys (peginterferon alfa-2a) and ribavirin, establishing a user fee goal of December 2002. The firm submitted the BLA in June for treatment of chronic hepatitis C in patients without cirrhosis and patients with cirrhosis with compensated liver disease (Pharmaceutical Approvals Monthly, June 2002, p. 3

Roche is granted priority review status for its combination therapy of Pegasys (peginterferon alfa-2a) and ribavirin, establishing a user fee goal of December 2002. The firm submitted the BLA in June for treatment of chronic hepatitis C in patients without cirrhosis and patients with cirrhosis with compensated liver disease (Pharmaceutical Approvals Monthly, June 2002, p. 3)

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