Women's Health Weekly
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Attention Deficit Hyperactivity Disorder
Amended NDA for treatment of pediatric ADHD patients resubmitted to FDA
August 25th, 2005
The U.S. Food and Drug Administration (FDA) has accepted for review the amended new drug application (NDA) for MTS (methylphenidate transdermal system) recently resubmitted by Shire Pharmaceuticals Group plc and Noven Pharmaceuticals, Inc. MTS is a transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. The NDA amendment includes new clinical data that address the efficacy, dosing, duration of wear, and tolerability of MTS. If approved, MTS would be available in 10 milligram (mg), 16 mg, 20 mg and 27 mg strengths. The FDA has confirmed that the amendment will receive a...
Source: Women's Health Weekly (2005-08-25)
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