FDA — authorised 27 June 2018
- Application: NDA210498
- Marketing authorisation holder: ARRAY BIOPHARMA INC
- Local brand name: MEKTOVI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Mektovi in United States
FDA authorised Mektovi on 27 June 2018
Marketing authorisations
FDA
- Status: approved
Mektovi 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 Mektovi approved in United States?
Yes. FDA authorised it on 27 June 2018; FDA has authorised it.
Who is the marketing authorisation holder for Mektovi in United States?
ARRAY BIOPHARMA INC holds the US marketing authorisation.