FDA Reviewing Chantix Postmarketing Data On Suicide, Erratic Behavior
This article was originally published in The Pink Sheet Daily
Early communication by the agency follows one case of erratic behavior leading to the death of a patient using the smoking cessation drug.
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Those patients need more options for smoking cessation, Pfizer says, but that is the group FDA most worries about when deciding whether to remove its boxed warning.
FDA will present concerns on data collection and study conduct during advisory committee meeting on removing smoking cessation drug's boxed warning.
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.