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
Approval Letter
(Text)
Label
(PDF),
(Text)
Medication Guide
(PDF),
(Text)
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)
|