April 7-8, 2009: Psychopharmacologic Drugs Advisory Committee Meeting Announcement
|CDER||April 7-8, 2009||8:00 a.m.-5:00 p.m.||Hilton Washington DC/Silver Spring|
8727 Colesville Road
Silver Spring, Maryland
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.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at:
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
- Yvette Waples
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093)
Rockville, MD 20857
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Yvette Waples at (301) 827-7001 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings.
Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).