Topic: discuss the question of whether or not dietary restrictions would be needed for the 20 mg dose for Emsam (selegiline transdermal system) [new drug applications (NDA) 21-336, short-term claim, and NDA 21-708, longer-term claim, Somerset Pharmaceuticals], for the treatment of major depressive disorder.
Overview of Issues and Questions Thomas Laughren, M.D.
FDA Presentation Gregory Dubitsky, M.D.
Division of Psychiatry Products, CDER
Introduction Melissa L. Goodhead, B.Sc., RAC- Moderator
Group Director, Regulatory Affairs/Quality Assurance
Somerset Pharmaceuticals, Inc.
Overview Sheldon Preskorn, M.D.
Department of Psychiatry
Medical Director, Somerset Pharmaceuticals, Inc.
of Dosing Instructions Director of Clinical Programs & Product Information
Questions and Answers Melvin Sharoky, M.D.
CEO and President, Somerset Pharmaceuticals, Inc.