FDA — authorised 9 January 2020
- Application: NDA212608
- Marketing authorisation holder: BLUEPRINT MEDICINES
- Local brand name: AYVAKIT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ayvakit in United States
FDA authorised Ayvakit on 9 January 2020
Marketing authorisation
Ayvakit 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 Ayvakit approved in United States?
Yes. FDA authorised it on 9 January 2020.
Who is the marketing authorisation holder for Ayvakit in United States?
BLUEPRINT MEDICINES holds the US marketing authorisation.