FDA — authorised 4 September 2012
- Application: NDA203341
- Marketing authorisation holder: PF PRISM CV
- Local brand name: BOSULIF
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Bosulif in United States
FDA authorised Bosulif on 4 September 2012
Marketing authorisations
FDA — authorised 26 September 2023
- Application: NDA217729
- Marketing authorisation holder: PF PRISM CV
- Local brand name: BOSULIF
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 May 2025
- Application: ANDA209543
- Marketing authorisation holder: ALEMBIC
- Local brand name: BOSUTINIB MONOHYDRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Bosulif in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Bosulif approved in United States?
Yes. FDA authorised it on 4 September 2012; FDA authorised it on 26 September 2023; FDA authorised it on 23 May 2025.
Who is the marketing authorisation holder for Bosulif in United States?
PF PRISM CV holds the US marketing authorisation.