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Thursday, 07/30/2009 4:38:37 PM

Thursday, July 30, 2009 4:38:37 PM

Post# of 320
FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) voted unanimously in favor of SAPHRIS(asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of youth in acute treatment of schizophrenia in adults. SAPHRIS could be the first psychotropic drug to be approved initially for both of these indications.

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