Chantix Faces FDA Safety Gauntlet After Pfizer Settles Product Liability Suits
This article was originally published in The Pink Sheet Daily
FDA advisory committees will discuss risk of serious neuropsychiatric adverse events with the smoking cessation drug at October meeting.
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Pfizer wants advisory committee to endorse several labeling changes for its smoking cessation drug, but FDA says decision should wait for post-marketing trial set to be completed in about a year.
Pfizer’s litigation department scored several key victories in the past year, which the company chalks up to its business approach to running cases and the teamwork of its law firms.
FDA's mandate, part of a response to neuropsychiatric adverse events that also includes boxed warnings for the smoking-cessation drugs, follows a trend of requesting sicker patients in trials.