Peginterferon alfa-2b Product Approval Information - Licensing Action

Proper name: Peginterferon alfa-2b
Tradename: PEG-Intron
Manufacturer: Schering Corp, Kenilworth, NJ, License #0994
Indication for Use: Combination therapy with Ribavirin, USP (Rebetol), for the treatment of chronic hepatitis C
Approval Date: 8/7/2001
Type of submission: Biologics license application supplement

Approval Letter (PDF)

Label (PDF)

Medication Guide (PDF)