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Article content The regulator said the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline. Canadian generic drugmaker Apotex will be temporarily allowed to distribute Apo-Varenicline tablets in the United States to help maintain adequate varenicline supply in the country for the near term, the FDA said. The nitrosamine impurity, called N-nitroso-varenicline, may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication, the FDA said. Risk of exposure to the carcinogen at interim acceptable intake levels up to 185 ng per day presents minimal additional cancer risk, compared with a lifetime exposure at the 37 ng per day level, the agency said.

United statesCynthia ostermanDevika syamnathTrisha roySabahatjahan contractorஒன்றுபட்டது மாநிலங்களில்சிந்தியா ஒஸ்டேர்மன்திரிஷா ராய்