The FDA is working to mitigate the national shortage of Pfizer's smoking cessation drug Chantix, which was recalled after the drugmaker discovered some pills contain elevated levels of N-nitroso-varenicline, a likely carcinogen.
Pfizer halted global distribution of Chantix in June after finding the elevated nitrosamine levels and recalled nine lots of the drug. In July, the FDA said it would allow drugmakers to sell generic versions of the drug even if they contain low levels of nitrosamines, as the health benefits of quitting smoking outweigh the risk from the drug. In August, Pfizer recalled four more lots of the drug.
Pfizer has yet to disclose a resolution timeline for the shortage. In the meantime, the FDA has tapped drugmakers Apotex and Par Pharmaceuticals to help address the shortage, according to CIDRAP News.
On July 16, the FDA increased its N-nitroso-varenicline intake limit from 37 nanograms per day to 185. This change made it possible for Canadian smoking cessation drug APO-Varenicline Tartrate to be sold in the U.S., as its N-nitroso-varenicline levels are 27 to 44 nanograms per 1 milligram tablet.
The FDA has contacted the drug's manufacturer, Apotex, about the possibility of importing APO-Varenicline Tartrate. The agency granted an approved abbreviated new drug application and emergency authorization for importation that expires Sept. 30.
The FDA has also collaborated with Par Pharmaceutical on an abbreviated new drug application for a generic version of the drug, which earned approval Aug. 11. The launch timeline is undetermined, but the FDA reported that the drug contained 3 nanograms of N-nitroso-varenicline per 1 milligram tablet.