FDA Guidance Addresses Wave Of Impurities In Popular Drugs

By Dave Simpson (September 1, 2020, 9:46 PM EDT) -- The U.S. Food and Drug Administration released guidance Tuesday to help drug companies detect and prevent unacceptable levels of nitrosamine impurities, which have been linked to cancer and triggered recalls of the blood pressure drug valsartan, diabetes drug metformin and heartburn drug ranitidine.

The most common nitrosamine impurity, n-nitrosodimethylamine, or NDMA, is classified by the FDA as a probable human carcinogen, and its discovery in the heartburn medication commonly known as Zantac led to the recall of that drug earlier this year.

"This guidance recommends steps including a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce...

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