Chantix Meta-Analyses Not Enough To Remove Boxed Warning, FDA Argues
This article was originally published in The Pink Sheet Daily
Executive Summary
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...
FDA’s Black Box Instant Replay: A Higher Standard To Remove
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.
Pfizer’s Effort To Remove Chantix Boxed Warning May Backfire
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.
Chantix Faces FDA Safety Gauntlet After Pfizer Settles Product Liability Suits
FDA advisory committees will discuss risk of serious neuropsychiatric adverse events with the smoking cessation drug at October meeting.