FDA — authorised 17 April 2018
- Marketing authorisation holder: RIGEL PHARMS INC
- Status: approved
🇺🇸 Tavalisse in United States
FDA authorised Tavalisse on 17 April 2018
Marketing authorisations
FDA — authorised 17 April 2018
- Application: NDA209299
- Marketing authorisation holder: RIGEL PHARMS
- Local brand name: TAVALISSE
- Indication: TABLET — ORAL
- Status: approved
Tavalisse in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Tavalisse approved in United States?
Yes. FDA authorised it on 17 April 2018; FDA authorised it on 17 April 2018.
Who is the marketing authorisation holder for Tavalisse in United States?
RIGEL PHARMS INC holds the US marketing authorisation.