FDA — authorised 27 June 2018
- Marketing authorisation holder: ARRAY BIOPHARMA INC
- Status: approved
🇺🇸 Braftovi in United States
FDA authorised Braftovi on 27 June 2018
Marketing authorisations
FDA — authorised 27 June 2018
- Application: NDA210496
- Marketing authorisation holder: ARRAY BIOPHARMA INC
- Local brand name: BRAFTOVI
- Indication: CAPSULE — ORAL
- Status: approved
Braftovi 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 Braftovi approved in United States?
Yes. FDA authorised it on 27 June 2018; FDA authorised it on 27 June 2018.
Who is the marketing authorisation holder for Braftovi in United States?
ARRAY BIOPHARMA INC holds the US marketing authorisation.