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