Details
Regulatory Determination / Use
Epidiolex (prescription cannabidiol) was approved in June 2018 for the treatment of seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.
As a part of FDA’s mission to perform surveillance of cannabidiol-containing products, a utilization analysis was conducted in Sentinel’s Merative™ MarketScan® Research Databases to inform feasibility of future studies.
Based on the available findings, FDA determined that no regulatory action was needed.