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.

There appeared to be little interest among FDA advisory committee members to rush adjustments to the labeling for Pfizer Inc.’s smoking cessation drug Chantix, especially with a clinical trial about to be completed that may answer the question.

The result seems to be a negative for Pfizer, which had submitted a supplemental application to make several labeling changes for Chantix (varenicline), a product

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