U.S. and European drug regulators said on Friday they are reviewing the safety o...
A view shows the U.S. Food and Drug Administration headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo
The U.S. Food and Drug Administration said it had found traces of the impurity, called N-nitrosodimethylamine , in some versions of drugs with ranitidine in them. Both the FDA and the European Medicines Agency said they will review the drug’s safety. Valisure said in its report that it found the impurities in both Sanofi SA’s branded Zantac as well as generic versions of the drug. But the FDA would not confirm in which versions of the drug it had found the impurities, noting that it found quite different - and lower - amounts of NDMA in the drugs.
NDMA is one of the impurities that has been found in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers . Regulators have been recalling those drugs since last year, and the FDA expanded its investigation of the impurities beyond that class of drugs last month.
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