Psychopharmacologic Drugs Advisory Committee
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. ยง552).
These redacted portions will appear as white space on the screen or on the
printed page.
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..
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.