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.
Somerset Pharmaceuticals, Inc.
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