Chantix Meta-Analyses Not Enough To Remove Boxed Warning, FDA Argues

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 Inc. may have to convince an advisory committee and FDA officials not to wait another year for a post-marketing trial to be completed before considering taking a boxed warning for severe neuropsychiatric events out of the Chantix label.

Data from a meta-analysis of several trials as well as observational studies that the company submitted in a labeling supplement for the smoking cessation drug was judged insufficient to justify...

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