FDA — authorised 20 July 2018
- Marketing authorisation holder: AGIOS PHARMS INC
- Status: approved
🇺🇸 Tibsovo in United States
FDA authorised Tibsovo on 20 July 2018
Marketing authorisations
FDA — authorised 20 July 2018
- Application: NDA211192
- Marketing authorisation holder: SERVIER
- Local brand name: TIBSOVO
- Indication: TABLET — ORAL
- Status: approved
Tibsovo 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 Tibsovo approved in United States?
Yes. FDA authorised it on 20 July 2018; FDA authorised it on 20 July 2018.
Who is the marketing authorisation holder for Tibsovo in United States?
AGIOS PHARMS INC holds the US marketing authorisation.