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Provigil (Modafinil) and Nuvigil (Armodafinil) & Congenital Cardiac and Non-Cardiac Malformations

    Basic Details
    Status
    Ongoing
    Last Updated
    Monday, November 13, 2023
    Original Posting Date
    Health Outcome(s)
    cardiac congenital malformations
    non-cardiac congenital malformations
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No