FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine( NDMA) and N-Nitrosodiethylamine( NDEA) impurities in ARB medicines.
Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products, our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug's active pharmaceutical ingredients.
That said, any presence of such impurities in drug products is not acceptable. It's important to underscore that, based on the FDA's initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure.
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