As of December 2010, FDA has received more than 662 proposed pediatric study requests from industry, and the Agency has issued 396 written requests for studies. More than 870 pediatric studies have been requested, involving more than 50,000 patients.
In 2009, exclusivity was granted to the majority of sponsors -- 155 drug moieties out of 175 determinations. The labeling changes that resulted from these data can be found at http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/ PediatricTherapeuticsResearch/UCM163159.pdf.
FDA has issued 19 off-patent written requests and has 12 studies ongoing. There have been no labeling changes through 2010.