Food and Drug Administration

Antiviral Drugs Advisory Committee

December 12, 2001

Topic: An update on the approval of BLA 103949/5002, PEG-Intron™ (peginterferon alfa-2b) Powder for Injection, indicated for use alone or in combination with Rebetol (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

Slides

Disclaimer

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.

Sponsor Presentation - Schering Corporation   [ppt]  [htm]

FDA Presentation   [ppt]  [htm]