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Medical News and Perspectives
February 8, 2006

FDA Speeds Smoking Cessation Drug Review

JAMA. 2006;295(6):614. doi:10.1001/jama.295.6.614

The Food and Drug Administration (FDA) has agreed to fast track its review of an experimental smoking cessation drug that studies suggest is more effective at helping smokers quit than the antidepressant bupropion at least in the short term. The drug, called varenicline, specifically targets the brain receptors responsible for mediating the reinforcing effects of nicotine.

The FDA granted priority review status to Pfizer's new drug application for varenicline in December, according to the company. This status is granted to drugs that represent a significant improvement over existing therapies in effectiveness and/or patient compliance or a reduction in adverse events.

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