Treats chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant…. Sold as Bosulif. Every FDA application for this active ingredient: 2 branded and 3 generic.
As of Nov 15, 2026, FDA lists 5 applications for Bosutinib Monohydrate (sold as Bosulif), first approved Sep 4, 2012, with 4 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid LeukemiaChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive · SWOG Cancer Research Network | Phase 2 | Active, not recruiting | Aug 31, 2018 |
| Sep 4, 2012 | BosulifNDA 203341 · New molecular entity | Pf Prism Cv | 19 | Marketed |
| Sep 26, 2023 | BosulifNDA 217729 · New dosage form | Pf Prism Cv | 2 | Marketed |
| May 23, 2025 | Bosutinib MonohydrateANDA 209543 | Alembic | 0 | Marketed |
| Jun 12, 2026 | Bosutinib Monohydrate, BosutinibANDA 209624 | Msn | 0 | Marketed |
| — | BosutinibANDA 209577 | Sun Pharm Industries | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Alembic
Sun Pharm Industries