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.