Bosutinib
Drug Details
- Generic Name
- Bosutinib
- Brand Names
- BOSULIF
- Application Number
- NDA217729
- Sponsor
- Pfizer Laboratories Div Pfizer Inc
- NDC Codes
- 12
- Dosage Forms
- CAPSULE, POWDER, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- BOSUTINIB MONOHYDRATE, BOSUTINIB
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 )