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The Food and Drug Administration (FDA) recently authorized a new formulation of ranitidine (formerly sold as Zantac) more than 5 years after the agency called for all versions of the drug to be withdrawn because of concerns that it could degrade into a carcinogenic compound. According to the agency, it has now approved VKT Pharma’s 150-mg and 300-mg ranitidine tablets after extensive safety testing and manufacturing improvements. There are also updated, more stringent storage instructions. In April 2020, all prescription and over-the-counter ranitidine products were removed from the market after FDA found that the products could form N-nitrosodimethylamine—a carcinogen—when stored above normal room temperature. In its recent guidance, the FDA emphasizes detailed storage protocols. For example, tablets should be kept in their original container and protected from moisture. Only 1 container should be opened at a time, and just 1 tablet should be taken out with each dose. The container should be tightly closed with the supplied desiccant left inside. The medication must be discarded 90 days after first opening or by its expiration date, whichever comes first.
Major market: As recently as 2018, Zantac was among the top 10 antacid tablet brands sold in the United States with $128.9 million in sales, according to a class action case filed against its manufacturer in 2019.