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Not a strong need for diet restricts at 40mg EMSAM

Posted by gibber on April 12, 2006, at 23:59:55

This is from: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4186B2_01_01_Somerset-EMSAM.pdf


Phase 3 outpatient exposure provides safety support for the use of this product without
dietary modifications. More than 2,656 patients were exposed to EMSAM 20 mg. Of
those patients, 947 were exposed to EMSAM 30 or 40 mg in Phase 3 clinical trials
(controlled and open-label) without dietary modification, and without a single episode of
hypertensive crisis.


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URL: http://www.dr-bob.org/babble/20060412/msgs/632451.html