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Uloric (Febuxostat) & Duration of Use and User Characteristics

    Basic Details
    Last Updated
    Thursday, November 12, 2020
    Original Posting Date
    Health Outcome(s)
    duration of use
    user characteristics
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    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.