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Dockets Management

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2005P-0420
CP 1
Volume 1

Citizen Petition

Exhibit A - Adderall XR MASP approved package insert Published Material

Exhibit B - Letter to Shire from Russell Katz, M.D., Director, Division of Neuropharmocological Drug Products , May 4, 1999

Exhibit C - FDA’s Minutes of Clinical Development Meeting with Shire Laboratories

Exhibit D - SLI 381.201. A randomized, double-blind, placebo- and active-controlled, crossover study of SLI 381 in children with attention deficit hyperactivity disorder, continued

Exhibit E - Swanson, James, et al. A Comparison of Once-Daily Extended-Release Methylphenidate Formulations in Children with Attention-Deficit/Hyperactivity Disorder in the Laboratory School, Pediatrics v 113, 3 (Mar 2004); e206-216 Published Material

Exhibit F - Data plots obtained from Shire pharmacokinetic trials SLI 381-103 (adult) and SLI 381-107 (pediatric)

Exhibit G - SLI 381.103. A pharmacokinetic study to compare to bioavailability of a 30 mg SLI381 capsule in healthy volunteers when administered as an intact capsule following an overnight fast, to an intact capsule administered with food, and to an open capsule (sprinkled on applesauce)

Exhibit H - SLI 381.107. A single-dose, bioequivalence study comparing 1 x 40 mg capsule of SLI381 to 4 x 10 mg capsule of SLI381 in pediatric subjects

Exhibit I - CV for Roger J. Porter, M.D.

Exhibit J - CV for Tom Ludden, Ph.D.


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