Ablysinol (Dehydrated Alcohol) & Atrioventricular Block, Death, Heart Failure, Septal Myectomy, and Ventricular Arrhythmia

    Basic Details
    Status
    Ongoing
    Last Updated
    Thursday, September 17, 2020
    Original Posting Date
    Health Outcome(s)
    atrioventricular block
    death
    heart failure
    septal myectomy
    ventricular arrhythmia
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Yes