The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, September 14, 2016 meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee. The Committees will discuss a completed postmarketing-requirement: a randomized, placebo-controlled trial of the neuropsychiatric effects of CHANTIX (varenicline), ZYBAN (bupropion), and nicotine replacement therapy, along with relevant published observational studies, to determine whether the findings support changes to product labeling.

See the SAC Tracker report