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Uloric (Febuxostat) & Duration of Use and User Characteristics

    Basic Details
    Status
    Complete
    Last Updated
    Thursday, November 12, 2020
    Original Posting Date
    Health Outcome(s)
    duration of use
    user characteristics
    Purpose
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No
    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.