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FDA pediatric research list

This article was originally published in The Tan Sheet

Executive Summary

Nicorette/Nicoderm CQ marketer SmithKline Beecham suggests agency request for more information on OTC nicotine in the adolescent population be expanded to 12- to 17-year-olds from FDA's proposed collection in 12- to 16-year-olds; current OTC nicotine replacement product labeling restricts usage of nicotine products to persons 18 and older. In March, FDA issued a list of drugs for which it seeks additional information on pediatric usage as required by the FDA Modernization Act. The list includes 22 other OTCs in addition to nicotine ("The Tan Sheet" March 30, p. 15). Additional pediatric information provided by companies at FDA's request could lead to six months of additional marketing exclusivity...
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