Interferon alfacon-1 Product Approval Information - Licensing Action 10/6/97

Proper name: Interferon alfacon-1
Tradename: Infergen
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Indication for Use: Treatment of chronic hepatitis C virus (HCV) infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA
Approval Date: 10/6/97
Type of submission: Biologics license application

Approval Letter (PDF)

Label (PDF)

SBA (PDF)