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Utilization of Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) That Employ Elements to Assure Safe Use (ETASU): A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    alosetron
    alvimopan
    clozapine
    collagenase clostridium histolyticum
    denosumab
    eculizumab
    idelalisib
    isotretinoin
    lenalidomide
    mifepristone
    mycophenolate
    natalizumab
    olanzapine extended release
    panobinostat
    phentermine/topiramate
    pomalidomide
    romiplostim
    teduglutide
    testosterone undecanoate
    vigabatrin
    Description

    In this request, we investigated utilization patterns of drugs with approved REMS (Risk Evaluation and Mitigation Strategies) that employ ETASU (Elements to Assure Safe Use).

    This analysis includes two reports:

    • Report 1: We executed this request on Merative™ MarketScan® Research Databases on May 5, 2021. The study period includes data from January 1, 2010 to September 30, 2019. Products assessed in this report include: collagenase clostridium histolyticum, isotretinoin, mycophenolate, lenalidomide, mifepristone, clozapine, phentermine/topiramate, eculizumab, natalizumab, and pomalidomide.
    • Report 2: We executed this request on Merative™ MarketScan® Research Databases on October 15, 2021. The study period includes data from January 1, 2010 to September 30, 2020. Products assessed in this report include: alvimopan, testosterone undecanoate, panobinostat, teduglutide, alosetron, denosumab, vigabatrin, idelalisib, romiplostim, and olanzapine extended release.
    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2010 – September 30, 2019; January 1, 2010 – September 30, 2020
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals
    Data Sources
    Merative™ MarketScan® Research Databases