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After reviewing the companys PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that authorizing this product would meet the requirement of protecting public health the statutory standard set by the 2009 Family Smoking Prevention and Tobacco Control Act

The FDA required the manufacturer Pfizer to do a clinical trial to determine whether those side effects were actually triggered by Chantix

A colonoscopy may also be too much for people with certain chronic diseases, such as severe heart failure

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