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Shire/New River NRP104 submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire and New River are seeking a pediatric indication for children ages six to 12 for the attention deficit/hyperactivity disorder therapy NRP104. New River submitted an NDA for the amphetamine prodrug Dec. 6, giving FDA an Oct. 6, 2006 standard review action date. Lower abuse liability is one of the key advantages the sponsors hope to claim vis-à-vis currently marketed stimulant ADHD agents. The firms reported positive Phase III data for the new molecular entity in May (Pharmaceutical Approvals Monthly June 2005, In Brief)...
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