Meeting of the Psychopharmacologic Drugs Advisory Committee: FDA: Seroquel XR & Serdolect

Meeting of the (FDA)Psychopharmacologic Drugs Advisory Committee.

April 7-8, 2009
8:00 a.m.-5:00 p.m.
Hilton Washington DC/Silver Spring
The Ballrooms
8727 Colesville Road
Silver Spring, Maryland
Telephone: 301-589-5200


Agenda
On April 7, 2009, the committee will discuss safety and efficacy issues with new drug application (NDA) 20-644, Serdolect (sertindole) tablets, Lundbeck USA, proposed for the treatment of schizophrenia. On April 8, 2009, the committee will discuss safety and efficacy issues of supplemental new drug applications (sNDAs) 22-047/S-010/S-011/S-012, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of major depressive disorder and sNDA 22-047/S-014/S-015, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of generalized anxiety disorder. Particular safety issues for discussion on April 8, 2009, regarding the Seroquel XR applications are concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia.

Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before March 27, 2009.
Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on both days. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 18, 2009.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 23, 2009.

FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512544
Please call the Information Line for up-to-date information on this meeting.
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*Serdolect is a drug to possibly augment with Clozaril. Serdolect/Sercloz: my 2008 article.

Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
This study is currently recruiting participants.
Verified by H. Lundbeck A/S, January 2009 : Seroquel vs. Serdolect current FDA drug trial.


U.S.FDA Advisory Committees Site.

FDA Advisory Committees: Human Drugs

Who is on the committee?

Psychopharmacologic Drugs Advisory Committee Roster:

Chair
Jorge Armenteros, M.D. --resume shows funded studies (some funding amounts are blackened out of document)
Expertise: Psychiatry & Behavioral Medicine
Term: 10/31/2005 - 06/30/2009
2199 Ponce De Leon Boulevard
Suite 304
Coral Gables, Florida 33134

Robert W. Buchanan, M.D.
Expertise: Psychiatry
Term: 01/18/2008 – 06/30/2011
Professor, Department of Psychiatry
University of Maryland School of Medicine
Maryland Psychiatric Research Center, Rm 1-19
Post Office Box 21247
Baltimore, Maryland 21228

Rochelle Caplan, M.D.
Expertise: Psychiatry
Term: 01/04/2007 - 06/30/2010
Professor
Semel Institute for Neuroscience and Human Behavior, UCLA
760 Westwood Plaza, Room 48-269
Los Angeles, California 90024

*Gail W. Griffith, M.L.S. (Consumer Representative)
Term: 01/18/2008 – 06/30/2011
Writer and Activist
Washington, District of Columbia 20009

** William Z. Potter, M.D., Ph.D.
Expertise: Non-Voting Industry Representative
Term: 06/10/2008 – 10/31/2011
351 North Sumneytown Pike
UG4C96
North Wales, Pennsylvania 19454-2505

Designated Federal Official
Yvette Waples, Pharm.D.
Advisors and Consultants Staff
Center for Drug Evaluation and Research
Food and Drug Administration,
FHSL Room 1079 HFD-021
5630 Fishers Lane
Rockville, Maryland 20857
E-mail: Yvette.Waples@fda.hhs.gov
(301) 827-7001
Fax: (301) 827-6776

Susan K. Schultz, M.D.
Expertise: Psychiatry
Term: 01/04/2007 - 06/30/2010
Associate Professor of Psychiatry
University of Iowa College of Medicine
2-207 Psychiatry Research
500 Newton Road
Iowa City, Iowa 52242-1000

Marcia J. Slattery, M.D., M.H.S.
Expertise: Psychiatry
Term: 01/04/2007 - 06/30/2010
Associate Professor of Psychiatry and Pediatrics
Head, Division of Child and Adolescent Psychiatry
Department of Psychiatry
University of Wisconsin School of Medicine and Public Health
6001 Research Boulevard
Madison, Wisconsin 53719

Robert F. Woolson, Ph.D.
Expertise: Biostatistics
Term: 01/18/2008 – 06/30/2011
Professor, Department of Biostatistics, Bioinformatics and Epidemiology
Medical University of South Carolina
135 Cannon Street, Suite 303
Post Office Box 250835
Charleston, South Carolina 29425