It’s, in fact, a clunky phrase, which the agency shortens to NDSRIs, to prove the chemical reaction that in the end forms the harmful chemical. Two of the biggest drugs that have NDSRIs are Pfizer’s Chantix, used to help people stop smoking, and Merck’s Januvia for diabetes.
As soon as drugs start showing up with NDMA in them, the FDA asks drugmakers to make sure their product doesn’t have nitrosamines too. The FDA also noted in its guidance earlier this month that it has learned that some drugmakers have been checking their drugs for known nitrosamines, such as NDMA, but not for newer NDSRIs.
The agency also stated that these companies that haven’t done so need to assess their products for NDSRIs by the end of the year.
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