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Re: Pseudonym's Cymbalta Journal: Day 21

Posted by pseudonym on October 1, 2004, at 3:26:40

In reply to Re: Pseudonym's Cymbalta Journal: Day 21 » pseudonym, posted by yznhymer on September 29, 2004, at 15:29:55

No, I'm not sure when marketing approval will be given. The FDA has given the approvable letter, but I'm unsure if there is an additional FDA action date. I surmise that the current negotation will be over the labeling, in particular, what tyramine dietary restrictions may or may not be required. Now, out of an abundance of caution, the FDA may mandate dietary restrictions despite the selegiline patch totally bypassing the gut.

In any case, Cymbalta and selegiline are two different weapons in the anti-depressant arsenal, and they definitely have different mechanisms of action. It's highly possible that EMSAM alone, or EMSAM + DLPA could be what you'll ultimately decide upon.


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