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FDA Panel Votes on OTC Nicotine Mouth Spray for Smoking Cessation

The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote). The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver…

Chantix Labeling Updated Following Pediatric Smoking Cessation Study

Results from a placebo-controlled study evaluating Chantix (varenicline; Pfizer) in pediatric patients 12-16 years of age showed that the smoking cessation treatment was not associated with a significant increase in abstinence rates in this patient population.