FDA Approves Reformulated Ranitidine

U.S. Food and Drug Administration approved VKT Pharma’s reformulated Ranitidine tablets in 150 mg and 300 mg strengths, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product’s shelf-life.

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