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These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 2012
Medication labelWhy this: Advisory · dailymed-prescription
Bosutinib tablets are indicated for the treatment of: Adult patients 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)]. Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)]. Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.
- generic_name
- bosutinib
- product_names
- Bosutinib
- ndc
- 75907-405, 75907-405-30
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en