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news.The FDA has accepted for review New River Pharmaceuticals' and Shire's investigational compound for the treatment of attention deficit and hyperactivity disorder in children aged 6-12.
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The compound, NRP104, is the subject of a collaborative development and commercialization agreement between New River and Shire. New River submitted the NDA on December 6, 2005.
“We are pleased that this NDA has been accepted for review,” commented Suma Krishnan, New River’s vice president, product development. “This represents a key milestone in NRP104’s regulatory development. We remain hopeful that this promising drug candidate will be approved and launched by the end of 2006.”
New River Pharmaceuticals is focused on developing novel pharmaceuticals that are generational improvements of widely prescribed drugs in large and growing markets.