![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » FDA Panels Support Removal of Black Box Label for Pfizer’s Chantix
FDA Panels Support Removal of Black Box Label for Pfizer’s Chantix
September 20, 2016
Two FDA advisory committees backed the removal of a black box label for Pfizer’s smoking cessation drug Chantix, citing the therapy’s risk-benefit ratio.
A post-marketing study of the drug demonstrated no increased risk of serious neuropsychiatric events linked to Chantix, leaving most of committee members convinced that the product should no longer carry a black box label.
A few committee members found the study inadequately powered to address adverse neuropsychiatric events such as suicidality and voted in favor of keeping the black box label.
Upcoming Events
-
21Oct