U.S. FDA Issues Complete Response Letter for Saphris (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

January 14, 2009 -- Schering-Plough Corporation today announced that the U.S. FDA has issued a complete response letter for SAPHRIS (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

The details can be read here.