Wednesday, April 01, 2020 2:20:38 PM
01:55 PM EDT, 04/01/2020 (MT Newswires) -- The US Food and Drug Administration said on Wednesday it is requesting manufacturers withdraw all prescription and over-the-counter ranitidine drugs, commonly known as Zantac, from the market immediately following an ongoing probe of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications.
"The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity," the regulator said. NDMA is a probable human carcinogen, a substance that could cause cancer.
GlaxoSmithKline (GSK), the initial maker of Zantac for heartburn and indigestion in the 1980s, later sold the US brand rights to Sanofi. It has since lost patent protection is is produced by several generic drug companies. Sanofi recalled branded Zantac products in October. GSK was down more than 1% in afternoon trading. Shares of other Zantac-makers were also sharply lower, including Mylan (MYL), Sanofi (SNY) and Teva (TEVA), amid a fall in broader markets and health care stocks.
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