FDA — authorised 25 June 2018
- Application: NDA210365
- Marketing authorisation holder: JAZZ PHARMS RES
- Status: supplemented
🇺🇸 Epidiolex in United States
FDA authorised Epidiolex on 25 June 2018
Marketing authorisations
FDA
- Status: approved
Other Metabolic approved in United States
Frequently asked questions
Is Epidiolex approved in United States?
Yes. FDA authorised it on 25 June 2018; FDA has authorised it.
Who is the marketing authorisation holder for Epidiolex in United States?
JAZZ PHARMS RES holds the US marketing authorisation.