FDA Clears Reformulated Ranitidine for US Market After Five-Year Absence

The FDA has approved reformulated ranitidine tablets, allowing their return to the US market after a five-year absence. GSK PLC, a major pharmaceutical company, is involved in various therapeutic areas, including respiratory, antiviral, and vaccines. GSK's financial metrics indicate strong profitability and a robust market position, despite some financial stress indicators. The approval comes after comprehensive safety assessments and production enhancements that resolved earlier issues related to the formation of N-nitrosodimethylamine impurities during storage.