U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix)
  1. Drug Safety and Availability

FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix)

Update [5/5/2022] 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.

FDA-published testing method to provide an option for regulators and industry to detect nitrosamine impurities
The link below is to an FDA-published testing method to provide an option for regulators and industry to detect nitrosamine impurities in varenicline drug substances and drug products. This method should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.
  • LC-ESI-HRMS method: A reverse phase LC method with HRMS detection for the determination of varenicline NDSRI in Chantix™ drug product or drug substance.

 

 
Back to Top