Food and Drug Administration
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
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