Epidiolex ema approval date epidyolex?

When was Epidiolex first approved (FDA approval date)?

Epidiolex (cannabidiol, or CBD) received its FDA approval in June 2018 for treating seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients 2 years of age and older. [1]

What was Epidiolex approved for on that date?

The initial FDA approval covered two rare, severe forms of epilepsy:
- Dravet syndrome
- Lennox-Gastaut syndrome
Both were for seizure types associated with these syndromes in the approved age group. [1]

Has Epidiolex’s FDA label expanded since the approval date?

Yes. After the initial 2018 approval, Epidiolex’s FDA labeling later expanded to include additional epilepsy indications beyond the original Dravet and Lennox-Gastaut approvals. [2]

Patent/exclusivity tracking (if you’re researching “approval date” for commercial reasons)

If your goal is to connect the approval date to market exclusivity or patent timelines, DrugPatentWatch.com maintains tracking pages for key dates and related filings. [2]

Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206998
[2] https://www.drugpatentwatch.com/p/epidiolex