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Adderall XR (SLI 381), for Attention Deficit Hyperactivity Disorder, Receives Approvable Letter From FDA BASINGSTOKE, ENGLAND -- August 6, 2001 -- Shire Pharmaceuticals Group pl announces today that Adderall XR™ (SLI 381), a once daily treatment under review for Attention Deficit Hyperactivity Disorder (ADHD), has received an 'approvable' letter from the US Food and Drug Administration (FDA). An approvable letter is an official communication from the FDA indicating that the agency is prepared to approve the new drug application upon the finalisation of the labeling and satisfaction of any outstanding issues specified in that letter. The New Drug Application (NDA), which was submitted to the FDA on 3 October 2000, was based on studies involving over 600 patients and was one of the largest ever medication trials in ADHD research. The positive results from these studies have been presented at various scientific meetings throughout the past year. Adderall XR is a once daily formulation containing the same active ingredients as Adderall® (mixed salts of a single entity amphetamine product), which was developed by Shire's drug delivery division, Shire Laboratories Inc., using the Microtrol® oral controlled release technology. Shire successfully markets Adderall in the US, where it is the US ADHD brand leader. Rolf Stahel, Chief Executive of Shire, commented, "We expect this once daily formulation of our well established product, Adderall, to be seen as a major benefit for patients, their families, and schools. We intend to respond rapidly to the FDA to address the comments raised in their approvable letter and look forward to making this new product available in the US as soon as possible. SOURCE: Shire Pharmaceuticals Group pl E-mail this page to a friend or colleague! To print, use this version