Mylotarg® (gemtuzumab ozogamicin)

BL 761060

Mylotarg® (gemtuzumab ozogamicin)

BL 761060

U.S. License Holder:

Wyeth Pharms. Inc.

Date of License:

September-01-2017

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


MYLOTARG (gemtuzumab ozogamicin) is a CD33-directed antibody-drug conjugate indicated for:

treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults;

treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – August/September 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. October 5, 2017

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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