PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE Hilton Hotel, The Ballrooms, Gaithersburg, MD 8:00 a.m. – 5:00 p.m. December 2, 2005 Slides The Committee will discuss new drug application ([NDA] 21-514), Daytrana™ (methylphenidate transdermal system), formerly proposed as Methypatch®, Shire Pharmaceuticals and Noven Pharmaceuticals, Inc. Proposed indication is for the treatment of attention deficit hyperactivity disorder (ADHD).
FDA Overview [HTML] [PPT]	Paul Andreason, M.D. Deputy Director, Division of Psychiatry Products, CDER, FDA
FDA Presentation [HTML] [PPT]	Robert Levin, M.D. Medical Officer Division of Psychiatry Products, CDER, FDA
Sponsor Presentation [HTML] [PPT]
Introduction	Douglas Hay, Ph.D. Senior Vice President Global Regulatory Affairs Shire Pharmaceuticals
ADHD: Current Treatment	Marc Lerner, M.D. Clinical Professor of Pediatrics University of California, Irvine
Clinical Efficacy of MTS in Children with ADHD	Liza Squires, M.D. Senior Director Global Clinical Medicine Shire Pharmaceuticals
MTS Safety Evaluations	Raymond Pratt, M.D. Shire Pharmaceuticals
MTS: Clinical Perspective	Sharon Wigal, Ph.D. Associate Clinical Professor of Pediatrics University of California, Irvine
Benefit/Risk Summary	Raymond Pratt, M.D. Shire Pharmaceuticals
Questions to the Committee [HTML] [PPT]