FDA — authorised 25 June 2018
- Application: NDA210365
- Marketing authorisation holder: JAZZ PHARMS RES
- Local brand name: EPIDIOLEX
- Indication: SOLUTION — ORAL
- Status: approved
FDA authorised Moderate-Dose Cannabidiol on 25 June 2018
Yes. FDA authorised it on 25 June 2018.
JAZZ PHARMS RES holds the US marketing authorisation.