Psychopharmacologic Drugs Advisory Committee


October 26, 2005




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.

[HTML]   [PPT]                                                         Director, Division of Psychiatry Products

                                                                                    CDER, FDA


FDA Presentation                                                       Gregory Dubitsky, M.D.

[HTML]   [PPT]                                                         Medical Officer

                                                                                    Division of Psychiatry Products, CDER


Sponsor Presentation                                                 Somerset Pharmaceuticals
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Introduction                                                       Melissa L. Goodhead, B.Sc., RAC- Moderator

                                                                                    Group Director, Regulatory Affairs/Quality Assurance

                                                                                    Somerset Pharmaceuticals, Inc.


            Overview                                                          Sheldon Preskorn, M.D.

                                                                                    Chairman, Department of Psychiatry
University of Kansas, Wichita


            Safety- Tyramine                                              Lawrence Blob, M.D.

                                                                                    Medical Director, Somerset Pharmaceuticals, Inc.


            Education & Communication                              Chad VanDenBerg, Pharm.D.

            of Dosing Instructions                                        Director of Clinical Programs & Product Information                 

            Conclusions                                                       Lawrence Blob, M.D.


Questions and Answers                                     Melvin Sharoky, M.D.

                                                                                    CEO and President, Somerset Pharmaceuticals, Inc.


                Somerset Pharmaceuticals Supporting Slides
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Questions to the Committee
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