www.fdanews.com/articles/179819-pfizer-announces-fda-will-no-longer-require-warning-label-for-its-chantix-medication
Pfizer Announces FDA Will No Longer Require Warning Label for Its Chantix Medication
December 23, 2016
Pfizer announced that the FDA will no longer require the company’s smoking-cessation pill Chantix to carry a warning about a potential link to suicide, depression and hostile behavior.
In addition, the label can now also state that Chantix works better than the nicotine patch and a generic smoking-cessation pill known as bupropion.
The FDA made its decision based on results from an 8,144-subject study probing the safety of Chantix and bupropion, sponsored by Pfizer and GlaxoSmithKline. The study found results from an 8,144-subject study probing the safety of Chantix and bupropion, sponsored by Pfizer and GlaxoSmithKline.