ADHD

Adderall XR gets 6 months pediatric exclusivity

Published in Health and Medicine Week, November 22nd, 2004

Shire Pharmaceuticals Group plc (SHP, SHPGY, SHQ) announced that the U.S. Food & Drug Administration (FDA) has granted an additional 6 months market exclusivity to Shire's Adderall XR (mixed amphetamine salts), the leading brand in the U.S for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The extension provides U.S market exclusivity until April 11, 2005, under the Hatch-Waxman regulations. In their letter, the FDA has confirmed that Shire has met the terms of a Written Request to provide data from a clinical program examining the effect of Adderall XR in adolescent pediatric patients. The additional studies performed under this agreement will...

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Source: Health and Medicine Week (2004-11-22)

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