Psychopharmacologic Drugs Advisory Committee

October 25, 2005

Briefing Information

 

On October 25, 2005, the committee will discuss issues and questions pertinent to the need for longer-term efficacy data for proposed drug treatments for chronic psychiatric disorders, and issues and questions pertinent to optimal study designs for obtaining valid information about longer-term benefits of drug treatment.

 

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. 552).
These redacted portions will appear as white space on the screen or on the printed page.

 

FDA Background Memo

 

 

SPONSOR

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA,
and FDA does not necessarily agree with the sponsor's statements..

 

Vanda Pharmaceuticals Inc.

 

 

On October 26, 2005, the committee will discuss the question of whether or not dietary restrictions would be needed for the 20 milligrams (mg) dose for proposed trade name EMSAM (selegiline transdermal system) (new drug applications (NDAs): NDA 21-336, short-term claim, and NDA 21-708, longer-term claim, Somerset Pharmaceuticals), for the treatment of major depressive disorder.

 

The materials for the October 26, 2005 session will be posted on October 25, 2005.