Editor’s note: The pediatric studies provision, recently reauthorized in 2002 by the Best Pharmaceuticals for Children Act (PL 107-109), requests drug companies to conduct pediatric studies for new drugs and drugs already on the market in exchange for an additional six months of market exclusivity. According to the U.S. Food and Drug Administration (FDA), there have been more than 656 new pediatric studies requested, with at least 116 studies completed since the law was implemented. The following list from the FDA includes the label changes that have been made as a result of these studies.

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