FDA label
What is Bosulif used for?
Bosulif contains bosutinib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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; Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy.”
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Bosulif, tablet, film coated
Indications and Usage, quoted from the label by U.S. Pharmaceuticals (NDA203341). Cross-references to other label sections are left out.
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.
- Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy.
Source: DailyMed label, set id d5929f91-6496-4c0e-97e8-0bd524e15763, version 6, effective May 28, 2026. NDC 63539-193, one of 4 listings for this product.
Questions
What is Bosulif used for?
The FDA label says: “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; Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy.”
What drug class is Bosulif?
FDA lists bosutinib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.