Application Nr Approved Date Route Status External Links
NDA022068 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tasigna Is A Kinase Inhibitor Indicated For The Treatment Of: Adult And Pediatric Patients Greater Than Or Equal To 1 Year Of Age With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ Cml) In Chronic Phase. ( 1.1 ) Adult Patients With Chronic Phase (Cp) And Accelerated Phase (Ap) Ph+ Cml Resistant To Or Intolerant To Prior Therapy That Included Imatinib. ( 1.2 ) Pediatric Patients Greater Than Or Equal To 1 Year Of Age With Ph+ Cml-Cp Resistant Or Intolerant To Prior Tyrosine-Kinase Inhibitor (Tki) Therapy. ( 1.3 ) 1.1 Adult And Pediatric Patients With Newly Diagnosed Ph+ Cml-Cp Tasigna Is Indicated For The Treatment Of Adult And Pediatric Patients Greater Than Or Equal To 1 Year Of Age With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ Cml) In Chronic Phase. 1.2 Adult Patients With Resistant Or Intolerant Ph+ Cml-Cp And Cml-Ap Tasigna Is Indicated For The Treatment Of Adult Patients With Chronic Phase And Accelerated Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ Cml) Resistant Or Intolerant To Prior Therapy That Included Imatinib. 1.3 Pediatric Patients With Resistant Or Intolerant Ph+ Cml-Cp Tasigna Is Indicated For The Treatment Of Pediatric Patients Greater Than Or Equal To 1 Year Of Age With Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ Cml) With Resistance Or Intolerance To Prior Tyrosine-Kinase Inhibitor (Tki) Therapy.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nilotinib NILOTINIB ZINC6716957

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