Chantix Meta-Analyses Not Enough To Remove Boxed Warning, FDA Argues
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
Pfizer’s request for leniency on Chantix will likely be shelved, but advisory committee allows exploration of regulatory area where FDA has limited experience: The rollback of safety labeling.
Most FDA advisory committee members vote to wait until clinical trial results are submitted, but some also say warning should be include additional adverse events.
FDA advisory committees will discuss risk of serious neuropsychiatric adverse events with the smoking cessation drug at October meeting.