FDA — authorised 14 November 2019
- Application: NDA213217
- Marketing authorisation holder: BEONE MEDICINES USA
- Local brand name: BRUKINSA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Brukinsa in United States
FDA authorised Brukinsa on 14 November 2019
Marketing authorisations
FDA — authorised 10 June 2025
- Application: NDA218785
- Marketing authorisation holder: BEONE MEDICINES USA
- Local brand name: BRUKINSA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Brukinsa 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 Brukinsa approved in United States?
Yes. FDA authorised it on 14 November 2019; FDA authorised it on 10 June 2025; FDA has authorised it.
Who is the marketing authorisation holder for Brukinsa in United States?
BEONE MEDICINES USA holds the US marketing authorisation.