SEP 14 PDAC-DSRM

The US FDA has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee for Wednesday, September 14, 2016. The Committees will discuss a postmarketing requirement that was completed by Pfizer Inc. (Pfizer) for Chantix (varenicline). The postmarketing requirement was a randomized, placebo-controlled trial of the neuropsychiatric effects of Chantix, Zyban (bupropion), and nicotine replacement therapy. The Committees will discuss these results and relevant published observational studies to determine if the findings support changes to product labeling.

See the SAC Tracker report