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

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

PR Newswire

PARSIPPANY, N.J., April 1, 2013

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:

  oThere are no significant safety concerns associated with the concomitant
    use of NRT products with other nicotine containing products.
  oThere are no significant safety risks associated with the use of NRT
    products for longer than the labeled 12 weeks of use.
  oCurrently 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

                        Deborah Bolding
GSK Consumer Healthcare                           (973) 889-2344
                        deborah.g.bolding@gsk.com
                        Catherine Bocke
GolinHarris                                       (312) 729-4483
                        cbocke@golinharris.com

SOURCE GlaxoSmithKline Consumer Healthcare

Website: http://www.gsk.com
 
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