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Zantac (Ranitidine) & Duration of Use

Basic Details
Status
Complete
Last Updated
Tuesday, September 15, 2020
Health Outcome(s)
duration of use
Purpose
Drug Utilization
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

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.

Result(s) (1)
Ranitidine Drug Utilization Patterns
Regulatory Link(s) (2)
FDA Updates and Press Announcements on NDMA in Zantac (ranitidine) Division of Drug Information webinar, May 5, 2020: Nitrosamine Impurities in Drugs: What Health Care Professionals Need to Know