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Utilization of Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) that Employ Elements to Assure Safe Use (ETASU)

    Basic Details
    Date Posted
    Medical Product
    drugs with REMS that employ ETASU

    These reports present counts of generic names contained in the National Drug Code (NDC) directory. Results include total counts, incidence, and prevalence of dispensing of the selected drugs (generic names) among enrolled members in the Sentinel Distributed Database (SDD). Counts and incidence are calculated with a 90-day washout period.

    The study period includes data from 2008 - 2017. We distributed this request to 17 Data Partners on February 6, 2019.

    Additional Details
    FDA Center
    Time Period
    2008 - 2017
    Analysis Type
    Summary Table
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)