FDA
- Application: ANDA217509
- Marketing authorisation holder: TEVA PHARMACEUTICALS USA, INC.
- Local brand name: BINIMETINIB
- Indication: TABLET
- Status: approved
🇺🇸 Mektovi in United States
Mektovi (binimetinib) regulatory status in United States.
Marketing authorisation
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 has authorised it.
Who is the marketing authorisation holder for Mektovi in United States?
TEVA PHARMACEUTICALS USA, INC. holds the US marketing authorisation.