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Attention Deficit Hyperactivity Disorder
Drugmaker provides update on regulatory status of Sparlon
February 27th, 2006
Cephalon, Inc., (CEPH) announced that it does not expect final action from the U.S. Food & Drug Administration (FDA) on its pending new drug application for Sparlon (modafinil) Tablets [C-IV] for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents until after the completion of several FDA advisory committee meetings. The first two panels, scheduled for February 9, 2006 and March 22, 2006, will consider safety and risk management issues associated with products in the class of currently approved ADHD treatments. Since Sparlon is not an approved drug, it will not be discussed at these meetings. A separate advisory panel to review...
Source: Pharma Business Week (2006-02-27)
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