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This is the first approval of generic version of Chantix, and it comes just weeks after a recall of the brand-name drug.
The FDA has approved the first generic version of Chantix (varenicline), Pfizer's smoking cessation product. Developed by Par Pharmaceutical, which is part of Endo International, the generic varenicline tablet was approved August 11, 2021. The generic will come in doses of 0.5 mg and 1 mg.
The approval of generic Chantix comes just a month after Pfizer stopped distribution and initiated a recall of Chantix because of high levels of a nitrosamine impurity, called N-nitroso-varenicline. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans. Pfizer expanded the initial recall from nine lots to 12.
The FDA allowed temporary importation of a generic from Canada to help meet the demand. for Chantix. Apotex Corp. initiated importation of apo-Varenicline 0.5 mg and 1 mg tablets into the U.S. market to address a shortage of the drug.
Apo-Varenicline is the varenicline tartrate product approved by Health Canada as a generic equivalent to Champix tablets manufactured by Pfizer Canada. Champix is the brand name of Chantix in Canada.
According to an FDA spokesperson, this importation was not related to the Safe Importation Action Plan, which became effective November 30, 2020. In this case, the FDA exercised regulatory flexibility and discretion to address drug shortages and mitigate any significant risk to patients.