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Merck Crixivan added to antiviral cmte. agenda March 1; Abbott ritonavir data show survival advantage.

Executive Summary

MERCK CRIXIVAN NDA ADDED TO FDA ADVISORY COMMITTEE AGENDA MARCH 1; Merck's protease inhibitor indinavir will be reviewed by FDA's Antiviral Drugs Advisory Committee the day after review of Abbott's ritonavir. The addition of Crixivan to the agenda was announced by FDA Jan. 31, the same day that Merck officially submitted NDA 20-685 for indinavir capsules for treatment of HIV. "The application for Crixivan has been submitted through the FDA's accelerated approval process," Merck said. Noting the rolling submission character of applications for AIDS drugs, Merck said it "has already reviewed a large portion of the data on Crixivan with FDA."
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