Food and Drug Administration

Antiviral Drugs Advisory Committee

November 14, 2002

Briefing Information


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Briefing Materials Updating Information the Safety and Efficacy of PEGASYS in Combination With COPEGUS for the Treatment of Adult Patients With Chronic Hepatitis C Infection, and to Discuss Questions about Dosing That May Result in Postmarketing Studies, FDA (HTM) (PDF) (Word)

FDA Briefing Package Cover Page, Dr. William Tauber, MD and Dr. Louis Marzella, MD, PhD, FDA (HTM) (PDF) (Word)

Briefing Document for PEGASYS in Combination with COPEGUS Treatment of Chronic Hepatitis C, Hoffmann-LaRoche, Inc. (PDF)