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Epidiolex (Prescription Cannabidiol) & Utilization

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

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