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Gilenya (Fingolimod) & Congenital Cardiac Malformations, Congenital Urinary Malformations, and all Congenital Malformations

    Basic Details
    Status
    Ongoing
    Last Updated
    Friday, March 3, 2023
    Original Posting Date
    Health Outcome(s)
    all congenital malformations
    congenital cardiac malformations (primary)
    congenital urinary malformations (primary)
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No