Despite its recommendation to remove the boxed warning from the label of Pfizer Inc.'s smoking cessation product Chantix, advisory committee members still may have provided FDA the ammunition to make the opposite decision. The agency has had fair bit of time to mull the issue following the panel meeting in September since the user fee date is not until this month.
Chantix's Boxed Warning: Will A Positive Vote Justify A Negative Outcome?
FDA could use advisory committee members' comments to maintain the smoking cessation drug's boxed warning, even though they voted to remove it.
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