The FDA approved reformulated ranitidine tablets, marking the acid-reducing drug’s return to the U.S. market after a five-year absence.
The updated formulation underwent safety testing and manufacturing revisions to address concerns about the formation of N-nitrosodimethylamine (NDMA), an impurity linked to cancer risk, during the drug’s shelf life, according to a Nov. 24 news release from the FDA.
Approved ranitidine products will carry revised labeling with storage and handling instructions. Patients are now instructed to keep tablets in the original container with a desiccant, use them within 90 days of opening and open only one bottle at a time if multiple are dispensed.
Ranitidine is a histamine-2 receptor antagonist indicated for gastroesophageal reflux disease, peptic ulcers and Zollinger-Ellison syndrome. The reformulated product maintains the same therapeutic effectiveness as earlier versions, the FDA said.
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