Pegasys® (peginterferon alfa-2a)

BL 103964

Pegasys® (peginterferon alfa-2a)

BL 103964

U.S. License Holder:

Hoffmann-La Roche

Date of License:

October-16-2002

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

PEGASYS (peginterferon alfa-2a) is an inducer of the innate immune response indicated for the treatment of:

Chronic Hepatitis C (CHC): Adult Patients: In combination therapy with other hepatitis C virus drugs for adults with compensated liver disease. Pegasys monotherapy is indicated only if patient has contraindication or significant intolerance to other HCV drugs; Pediatric Patients: In combination with ribavirin for pediatric patients 5 years of age and older with compensated liver disease:

Chronic Hepatitis B (CHB): Adult Patients: Treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) infection who have compensated liver disease and evidence of viral replication and liver inflammation; Pediatric Patients: Treatment of non-cirrhotic pediatric patients 3 years of age and older with HBeAg-positive CHB and evidence of viral replication and elevations in serum alanine aminotransferase (ALT).

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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