Bosutinib

FDA Drug Profile — BOSULIF

Drug Details

Generic Name
Bosutinib
Brand Names
BOSULIF
Application Number
NDA203341
Sponsor
MSN Laboratories Private Limited
NDC Codes
12
Dosage Forms
POWDER, TABLET, FILM COATED, CAPSULE
Routes
ORAL
Active Ingredients
BOSUTINIB, BOSUTINIB MONOHYDRATE

Indications and Usage

1 INDICATIONS AND USAGE BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 )