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Article: The FDA approves new drug for smoking cessation.(Food and Drug Administration approves Chantix)
- Article from:
- FDA Consumer
- Article date:
- July 1, 2006
CopyrightCOPYRIGHT 2006 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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 rather than the 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 have a superior rate of smoking cessation ...