Statement from GlaxoSmithKline Consumer Healthcare on FDA Report Regarding FDA's Changes to the Labeling of Over-the-Counter Nicotine Medications

PARSIPPANY, N.J., April 1, 2013 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced a recommendation to remove certain warning statements and modifications of the instructions for use of nicotine replacement therapy (NRT) products.

As leaders in smoking cessation, GlaxoSmithKline (GSK) Consumer Healthcare commends the FDA on this action and believes this is a positive step to help more smokers quit and will work with the FDA to implement these changes to our product labeling as soon as possible. The changes help eliminate barriers for smokers and include updates to the warnings and directions sections in the current label.

The FDA's conclusions include:

• There are no significant safety concerns associated with the concomitant use of NRT products with other nicotine containing products.
• There are no significant safety risks associated with the use of NRT products for longer than the labeled 12 weeks of use.
• Currently marketed NRT products do not appear to have significant potential for abuse or dependence.

FDA makes these recommendations based on extensive and reassuring safety and efficacy research on over-the-counter NRT, like Nicorette and NicoDerm CQ, which have helped millions of smokers around the world quit by gradually weaning them off of their tobacco addiction. NRT products have been studied in more than 110 clinical trials involving more than 40,000 participants demonstrating their safety and efficacy profile.

About GlaxoSmithKline Consumer Healthcare
GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its well-known brands include Nicorette® and NicoDerm® CQ, the leading smoking cessation products; alli, the only FDA-OTC weight loss aid; as well as medicine cabinet staples, Aquafresh®, Sensodyne,® Tums® and Breathe Right,® all of which are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

About GlaxoSmithKline
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.

Media Relations

SOURCE GlaxoSmithKline Consumer Healthcare

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