The first generic version of Chantix (varenicline) has been made available by Par Pharmaceutical, Inc.
Varenicline is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. The generic product is supplied as 0.5mg and 1mg tablets.
Par’s generic version of Chantix is currently the only available one in the US. The approval of the Abbreviated New Drug Application comes after Pfizer recently recalled all lots of Chantix 0.5mg and 1mg tablets due to the presence of a nitrosamine impurity above the Food and Drug Administration’s acceptable daily intake limit. The full list of recalled Chantix products can be found here.
“This important approval brings the first Chantix® generic to the US market,” said Jon Holden, Senior Vice President and General Manager, Generics at Endo. “As a reliable, quality supplier, Par is proud to help people during this critical time while also expanding our product portfolio.”
Endo launches first and only generic version of Chantix® (varenicline) tablets in the United States. News release. Endo International plc. Accessed September 22, 2021. https://www.prnewswire.com/news-releases/endo-launches-first-and-only-generic-version-of-chantix-varenicline-tablets-in-the-united-states-301382946.html.