FDA — authorised 17 November 2016
- Application: NDA203341
- Marketing authorisation holder: PF PRISM CV
- Indication: Labeling
- Status: approved
🇺🇸 Bosulif in United States
FDA authorised Bosulif on 17 November 2016
Marketing authorisations
FDA — authorised 3 December 2024
- Application: NDA217729
- Marketing authorisation holder: PF PRISM CV
- Indication: Labeling
- Status: approved
The FDA approved Bosulif (bosutinib), a kinase inhibitor, for the treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy, including tyrosine kinase inhibitors (TKIs). This approval was based on a standard application. Bosulif is manufactured by PF PRISM CV.
FDA
- Application: ANDA209624
- Marketing authorisation holder: MSN LABORATORIES PRIVATE LTD
- Local brand name: BOSUTINIB
- Indication: TABLET — FILM COATED
- 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 17 November 2016; FDA authorised it on 3 December 2024; FDA has authorised it.
Who is the marketing authorisation holder for Bosulif in United States?
PF PRISM CV holds the US marketing authorisation.