FDA approves reformulated ranitidine tablets

The U.S. Food and Drug Administration approved reformulated ranitidine tablets, “marking the return of this important acid-reducing medication to the U.S. market after a five-year absence,” the agency announced. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine impurity formation during the product’s shelf-life. Ranitidine, an H2 receptor antagonist, is widely used to treat conditions including gastroesophageal reflux disease, peptic ulcers, and Zollinger-Ellison syndrome.