Application Nr Approved Date Route Status External Links
BLA761060 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Mylotarg Is A Cd33-Directed Antibody And Cytotoxic Drug Conjugate Indicated For: Treatment Of Newly-Diagnosed Cd33-Positive Acute Myeloid Leukemia (Aml) In Adults And Pediatric Patients 1 Month And Older ( 1.1 ). Treatment Of Relapsed Or Refractory Cd33-Positive Aml In Adults And Pediatric Patients 2 Years And Older ( 1.2 ). 1.1 Newly-Diagnosed Cd33-Positive Acute Myeloid Leukemia (Aml) Mylotarg Is Indicated For The Treatment Of Newly-Diagnosed Cd33-Positive Acute Myeloid Leukemia In Adults And Pediatric Patients 1 Month And Older. 1.2 Relapsed Or Refractory Cd33-Positive Aml Mylotarg Is Indicated For The Treatment Of Relapsed Or Refractory Cd33-Positive Acute Myeloid Leukemia In Adults And Pediatric Patients 2 Years And Older.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Gemtuzumab Ozogamicin

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