Peginterferon alfa-2a Product Approval Information - Licensing Action

Proper name: Peginterferon alfa-2a
Tradename: PEGASYS
Manufacturer: Hoffman-La Roche, Inc, Nutley, NJ, License #0136
Indication for Use: Treatment of adults with chronic hepatitis C who have compensated liver disease and who have not been previously treated with interferon alfa
Approval Date: 10/16/2002
Type of submission: Biologics license application

Label (PDF)

Medication Guide (PDF)

Reviews
    CMC/Product Initial Review (PDF)
    Preclinical Review (PDF)
    Clinical Pharmacology (PDF)
    Clinical Initial Review (PDF)
    Clinical Final Review of Resubmission (PDF)
    Statistical Review (PDF)