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.

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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.

Schering Corporation  [pdf version] [htm version] [Word version]

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Food and Drug Administration

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