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Ablysinol (Dehydrated Alcohol) & Atrioventricular Block, Death, Heart Failure, Myocardial Infarction, Permanent Pacemaker Placement, Septal Myectomy, and Ventricular Arrhythmia

    Basic Details
    Status
    Ongoing
    Last Updated
    Thursday, February 9, 2023
    Original Posting Date
    Health Outcome(s)
    atrioventricular block
    death
    heart failure
    myocardial infarction
    permanent pacemaker placement
    septal myectomy
    ventricular arrhythmia
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Yes