Epidiolex approval date?

When was Epidiolex first approved?

Epidiolex (cannabidiol) was approved by the U.S. Food and Drug Administration (FDA) on June 25, 2018 for treating seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients aged 2 years and older. [1]

When did FDA approve Epidiolex for additional seizure types?

After the initial approval in 2018, the FDA later expanded Epidiolex’s approved use to include treatment of seizures associated with Tuberous Sclerosis Complex (TSC) (including TSC-associated seizures in patients 1 year of age and older). [1]

Why do some sources show different “approval” dates?

Some sites list the initial FDA approval date (2018) while others show later label expansions (such as the TSC indication). If you see more than one date, it usually corresponds to an approval for a new indication rather than the first time the drug was cleared. [1]

Source

[1] https://www.drugs.com/epidiolex.html