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:

November-30-2018

approved_indications FDA-Approved Indications


PEGASYS (peginterferon alfa-2a) is an antiviral indicated for:

Treatment of Chronic Hepatitis C (CHC) as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs in patients 5 years of age and older with compensated liver disease.

PEGASYS monotherapy is indicated for:

CHC only if patient has contraindication to or significant intolerance to other HCV antiviral drugs;

Treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation.

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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