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Attention Deficit Hyperactivity Disorder



U.S. FDA accepts new drug application for NRP104 as treatment for ADHD



February 27th, 2006

New River Pharmaceuticals Inc. (NRPH) announced that the U.S. Food & Drug Administration (FDA) accepted for review the company's new drug application (NDA) for NRP104 for attention deficit hyperactivity disorder (ADHD).

New River submitted the NDA seeking approval to manufacture and market the investigational compound for the treatment of ADHD in pediatric populations (ages 6-12). NRP104 is the subject of a collaborative development and commercialization agreement between New River and Shire plc (SHP; SHPGY; SHQ).

The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a...


Source: Pharma Business Week (2006-02-27)

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