Zevalin® (ibritumomab tiuxetan)

BL 125019

Zevalin® (ibritumomab tiuxetan)

BL 125019

U.S. License Holder:

Spectrum Pharms.

Date of License:

February-19-2002

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

ZEVALIN (ibritumomab tiuxetan) is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with:

Relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL);

Previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy.

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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