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