FDA — authorised 12 December 2018
- Application: NDA210365
- Marketing authorisation holder: JAZZ PHARMS RES
- Indication: Labeling
- Status: approved
🇺🇸 Epidiolex in United States
FDA authorised Epidiolex on 12 December 2018
Marketing authorisation
Epidiolex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Epidiolex approved in United States?
Yes. FDA authorised it on 12 December 2018.
Who is the marketing authorisation holder for Epidiolex in United States?
JAZZ PHARMS RES holds the US marketing authorisation.