Uloric (Febuxostat) & Duration of Use and User Characteristics

Basic Details
Status
Complete
Last Updated
Thursday, March 7, 2019
Health Outcome(s)
duration of use
user characteristics
Purpose
Drug Use
Regulatory Determination / Use

FDA conducted a study to further investigate a post-market clinical trial that identified an elevated risk of cardiovascular events. Sentinel was used to describe the real-world utilization of urate lowering therapies to help inform the committee’s determination that a population exists for whom the benefit-risk is favorable.