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Removing Pfizer's Chantix Boxed Warning A One-Off, Committee Says

Executive Summary

Advisory committee says data supports dialing back safety label for the smoking cessation product, but shouldn’t be precedent setting.

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FDA Makes Rare Call, Removes Boxed Warning From Chantix, Zyban Labels

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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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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.

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