FDA — authorised 3 August 2017
- Application: NDA209401
- Marketing authorisation holder: JAZZ PHARMS THERAP
- Status: supplemented
🇺🇸 Vyxeos in United States
FDA authorised Vyxeos on 3 August 2017
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Vyxeos approved in United States?
Yes. FDA authorised it on 3 August 2017; FDA has authorised it.
Who is the marketing authorisation holder for Vyxeos in United States?
JAZZ PHARMS THERAP holds the US marketing authorisation.