Category: Warning/Recalls Region: North America · United States Company: Pfizer Inc

Pfizer has failed to convince the US FDA to remove a black box warning on its quit-smoking drug Chantix

Pfizer has failed to convince the US FDA to remove a black box warning on its quit-smoking drug Chantix
An advisory panel to the agency voted against the removal this wee,k but agreed to revisit the issue once data from Pfizer's post-marketing study for Chantix (varenicline) is available. The firm is currently conducting a study on 8,000 people comparing Chantix with two other smoking-cessation treatments and a placebo in terms of possible serious neuropsychological effects. Data from the study is expected in the third quarter of 2015. Steve Romano, senior vice president of Pfizer's global innovative pharmaceutical business, told Reuters:

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