FDA - Notice on Chantix

The Food and Drug Administration (FDA or Agency) had determined that CHANTIX (varenicline tartrate) tablets, 0.5 milligram (mg) and 1 mg, has not been withdrawn from sale for reasons of safety or effectiveness to the extent that the drug can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

IDRAC_360729_28-Feb-2023_Federal Register_ Determination That CHANTIX (Varenicline Tartrate) Tablets.pdf (174.6 KB)


It’s a bit ironic that a smoking cessation medication (short term) is withdrawn for having nitrosamines. And that cigarettes are sold… There is a lot of legalistic and unscientific criteria about risk benefit…


Yes you are absolutely right! Industries are pumping lots of money and strength to comply this constrain limit. Instead of this cigarette should be banned.