Food and Drug Administration
Antiviral Drugs Advisory Committee
November 14, 2002
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)