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The FDA approves new drug for smoking cessation.(Food and Drug Administration approves Chantix)

Publication: FDA Consumer
Publication Date: 01-JUL-06
Format: Online
Delivery: Immediate Online Access

Article Excerpt
In May 2006, the Food and Drug Administration approved Chantix (varenicline tartrate) tablets to help cigarette smokers ages 18 and older stop smoking.

The drug received a priority review because of its significant potential benefit to public health. Chantix was reviewed in six months the...

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...rather than regular review time of 10 months, says Curt Rosebraugh, M.D., M.P.H., deputy director of the FDA's Office of Drug Evaluation II. "Chantix underwent priority review," Rosebraugh says, "because at the time the application was filed, a preliminary review of the efficacy studies indicated that smokers treated with Chantix may...

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