Psychopharmacologic Drugs Advisory Committee

 

October 26, 2005

 

Slides

 

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
[HTML]   [PPT]

 

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
                [HTML]   [PPT]

 

 

Questions to the Committee
[HTML]   [PPT]