Apotex to Import Generic of Chantix from Canada

Apotex Corp., in coordination with the FDA, has initiated temporary importation of Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg tablets into the U.S. market to address a drug shortage related to the recall of Chantix (varenicline), Pfizer's smoking cessation product. 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.

In July 2021, Pfizer stopped distribution and initiated Chantix because of high levels of nitrosamine impurity, called N-nitroso-varenicline. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans. On Monday, Pfizer expanded it recall from 9 lots to 12 lots.

The regulatory agency said, however, that there was no immediate risk to cancer patients, and that increased cancer risk would be associated with long-term use of Chantix.

The FDA announced on Friday, July 16, that it would allow an interim limit of 185 ng per milliliter a day until the impurity can be eliminated or reduced.

According to an FDA spokesperson, this is 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. 

"FDA evaluates the needs of the market and specific situations to determine when to exercise this type of discretion under controlled circumstances," the spokesperson said in an email. "In certain shortage situations, the temporary exercise of regulatory flexibility and discretion has proven to be an important tool in helping to alleviate a drug shortage and to ensure access to treatment options for patients in critical need."