Peginterferon alfa-2b Approval Information - Licensing Action

Proper name: Peginterferon alfa-2b
Tradename: PEG-Intron
Manufacturer: Schering Corp, Kenilworth, NJ, License #0994
Indication for Use: Treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease and are at least 18 years of age
Approval Date: 1/19/2001
Type of submission: Biologics license application

Approval Letter (PDF)

Label (PDF)

Medication Guide (PDF)

Summary Review (PDF)

Pharmacology Review (PDF)

Clinical Review (PDF)

Toxicologist's Review (PDF)

Clinical Review (PDF)