Skip to main content

Epidiolex (Prescription Cannabidiol) & Utilization

Basic Details
Status
Complete
Last Updated
Thursday, April 27, 2023
Original Posting Date
Health Outcome(s)
utilization
Purpose
Drug Use
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
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.

 

Result(s) (1)
Epidiolex (prescription cannabidiol) Utilization Patterns: A Descriptive Analysis