FDA — authorised 29 May 2013
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Status: approved
🇺🇸 Tafinlar in United States
FDA authorised Tafinlar on 29 May 2013
Marketing authorisations
FDA — authorised 29 May 2013
- Application: NDA202806
- Marketing authorisation holder: NOVARTIS
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 27 February 2024
- Application: NDA217514
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
The FDA approved Tafinlar, a medication developed by Novartis, for its approved indication on February 27, 2024. The application number for this approval is NDA217514. This approval was granted through the standard expedited pathway.
Tafinlar 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 Tafinlar approved in United States?
Yes. FDA authorised it on 29 May 2013; FDA authorised it on 29 May 2013; FDA authorised it on 27 February 2024.
Who is the marketing authorisation holder for Tafinlar in United States?
NOVARTIS PHARMS CORP holds the US marketing authorisation.