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This morning, Schering-Plough (NYSE: SGP) announced that the European Medicines Agency (EMEA) acccepted for review the company's Marketing Authorisation Application for asenapine. If approved, it will be sold as Sycrest in the form of a tablet for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. Currently, the U.S. Food and Drug Administration is reviewing a new-drug application for asenapine under the brand name Saphris.
SGP noted that it "highlighted asenapine as one of the Five Stars in our late-stage research and development pipeline at our R&D Update meeting in November 2008. At that time, we said that our aspirational filing date for asenapine in Europe was in 2009."
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