FDA — authorised 10 October 2014
- Application: NDA205718
- Marketing authorisation holder: HELSINN HLTHCARE
- Local brand name: AKYNZEO
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Akynzeo in United States
FDA authorised Akynzeo on 10 October 2014
Marketing authorisations
FDA — authorised 19 April 2018
- Marketing authorisation holder: HELSINN HLTHCARE
- Status: approved
FDA — authorised 19 April 2018
- Application: NDA210493
- Marketing authorisation holder: HELSINN HLTHCARE
- Local brand name: AKYNZEO
- Indication: POWDER — INTRAVENOUS
- Status: approved
Akynzeo 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 Akynzeo approved in United States?
Yes. FDA authorised it on 10 October 2014; FDA authorised it on 19 April 2018; FDA authorised it on 19 April 2018.
Who is the marketing authorisation holder for Akynzeo in United States?
HELSINN HLTHCARE holds the US marketing authorisation.