Psychopharmacologic Drugs Advisory Committee
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.
Portions of this document
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These redacted portions will appear as white space on the screen or on the printed page.
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..
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.