Pfizer Resubmits Thousands Of Adverse Chantix Reports

Law360, New York (May 20, 2011, 4:11 PM EDT) -- The U.S. Food and Drug Administration said Thursday that Pfizer Inc. last year resubmitted thousands of adverse event reports over its anti-smoking drug Chantix at the regulator's request.

The initial way those reports were sent to the FDA did not allow for a comprehensive evaluation, the agency said in a statement on its website. The regulator mandated more restrictive labeling in 2009 for the drug, which remains at the center of multidistrict litigation in which Pfizer is accused of downplaying Chantix's side effects. The resubmission included...
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