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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer's Chantix for smoking cessation: Labeling for Pfizer's newly approved selective nicotinic acetylcholine receptor partial agonist Chantix (varenicline) for smoking cessation includes superiority claims over GlaxoSmithKline's Zyban (bupropion). In one study, 44% of Chantix patients were abstinent in treatment weeks nine through 12 compared to 30% of Zyban patients and 17% on placebo, labeling says. Additionally, 29% of Chantix patients were continuously abstinent through the end of treatment compared to 23% of Zyban patients. On May 10, Chantix (formerly Champix) became the first nicotine agonist approved by FDA and the first new prescription medication approved for smoking cessation in nearly a decade. Roll-out of the tablet therapy is slated for the second half of the year...

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