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Ranexa (Ranolazine) & Seizure

    Basic Details
    Status
    Complete
    Last Updated
    Thursday, January 3, 2019
    Health Outcome(s)
    seizure
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No
    Regulatory Determination / Use

    Combined with evidence from the Centers for Medicare & Medicaid Services, risk of seizure was determined to be driven primarily by underlying comorbidities. FDA decided that no action is necessary at this time, based on available information.