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Epidiolex (Prescription Cannabidiol) & Utilization

    Basic Details
    Last Updated
    Thursday, April 27, 2023
    Original Posting Date
    Health Outcome(s)
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    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.