FDA — authorised 4 September 2020
- Marketing authorisation holder: BLUEPRINT MEDICINES
- Status: approved
🇺🇸 Gavreto in United States
FDA authorised Gavreto on 4 September 2020
Marketing authorisations
FDA — authorised 4 September 2020
- Application: NDA213721
- Marketing authorisation holder: RIGEL PHARMS
- Local brand name: GAVRETO
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 December 2020
- Application: NDA214701
- Marketing authorisation holder: BLUEPRINT MEDICINES
- Local brand name: GAVRETO
- Indication: CAPSULE — ORAL
- Status: approved
Gavreto 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 Gavreto approved in United States?
Yes. FDA authorised it on 4 September 2020; FDA authorised it on 4 September 2020; FDA authorised it on 1 December 2020.
Who is the marketing authorisation holder for Gavreto in United States?
BLUEPRINT MEDICINES holds the US marketing authorisation.