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N‐nitrosodimethylamine (NDMA)‐Contaminated and Non‐NDMA‐Contaminated Valsartan Use: A Descriptive Analysis

    Basic Details
    Date Posted
    Friday, February 18, 2022
    Status
    Complete
    Medical Product
    valsartan
    Description

    In this report we examined counts of individuals with N-nitrosodimethylamine (NDMA)-contaminated and non-NDMA-contaminated valsartan use in the Sentinel Distributed Database (SDD), and assessed the duration of database enrollment following the first eligible dispensing. The study period includes data from May 1, 2011 to October 31, 2020. We distributed this request to seven Sentinel Data Partners on December 18, 2020.

    Additional Details
    FDA Center
    CDER
    Time Period
    May 1, 2011 - October 31, 2020
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Individuals aged 18 and older
    Data Sources
    Sentinel Distributed Database (SDD)