FDA — authorised 12 December 2022
- Application: NDA216340
- Marketing authorisation holder: BRISTOL
- Local brand name: KRAZATI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 MRTX849 in United States
FDA authorised MRTX849 on 12 December 2022
Marketing authorisation
MRTX849 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 MRTX849 approved in United States?
Yes. FDA authorised it on 12 December 2022.
Who is the marketing authorisation holder for MRTX849 in United States?
BRISTOL holds the US marketing authorisation.