GSK Consumer Healthcare commends FDA nicotine replacement therapy proposals

PARSIPPANY, N.J. — GlaxoSmithKline Consumer Healthcare today commended the proposals by the U.S. Food and Drug Administration after the administration announced recommendations to remove certain warning statements and modifications of the instructions for use of nicotine replacement therapy products.

According to the statement released by GSK Consumer Healthcare:

"As leaders in smoking cessation, GlaxoSmithKline 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."

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