FDA — authorised 29 May 2013
- Application: NDA204114
- Marketing authorisation holder: NOVARTIS
- Local brand name: MEKINIST
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Mekinist in United States
FDA authorised Mekinist on 29 May 2013
Marketing authorisations
FDA — authorised 16 March 2023
- Application: NDA217513
- Marketing authorisation holder: NOVARTIS
- Local brand name: MEKINIST
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Mekinist (trametinib), a prescription medication, for its approved indication on 27 February 2024. Mekinist is marketed by Novartis. The application number for this approval is NDA217513. Mekinist was approved through the standard expedited pathway.
Mekinist 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 Mekinist approved in United States?
Yes. FDA authorised it on 29 May 2013; FDA authorised it on 16 March 2023.
Who is the marketing authorisation holder for Mekinist in United States?
NOVARTIS holds the US marketing authorisation.