Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee

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.

Briefing Information

Somerset Pharmaceuticals, Inc.

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. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Somerset Pharmaceutical Briefing Materialon EMSAM

Somerset Pharmaceutical Briefing Material Errata Sheet

 

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.

Division Director Memo

FDA Background Material on EMSAM