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Zantac (Ranitidine) & Duration of Use

    Basic Details
    Last Updated
    Tuesday, September 15, 2020
    Health Outcome(s)
    duration of use
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    This analysis provided information on use patterns of prescription ranitidine in patients with Medicare and private health care insurance. These data, in addition to data from other sources, were used to provide context for CDER’s Nitrosamine Impurities Task Force to better understand the use patterns among U.S. individuals. These data also informed the feasibility of a Sentinel analysis to evaluate clinical outcomes associated with prescription ranitidine use.