FDA Updates Regulatory Flexibility Concerning N-nitroso-varenicline Intake Limits
FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit of 37 ng per day. Any newly manufactured varenicline for the U.S. market should have levels of the N-nitroso-varenicline impurity at or below that limit.
In July 2021, FDA announced it would not object to certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit, but below the interim acceptable intake limit of 185 ng per day, until the impurity could be eliminated or reduced to acceptable levels. The agency’s current assessment shows manufacturers can adequately supply the market with varenicline at or below the acceptable intake limit of 37 ng per day.
FDA reminds patients taking varenicline to continue taking their current medicine unless their doctor prescribes a different treatment. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.
FDA continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public.
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