S-P responds to FDA's questions on Saphris NDA

2 March 2009

US drug major Schering-Plough has responded to the Food and Drug Administration's complete response letter for Saphris (asenapine) sublingual tablets, which it received in January. The letter proposed labeling for both indications and asked for supplemental data from the existing asenapine database but not for additional clinical trials. The agent is under review for the acute treatment of schizophrenia in adults and for acute manic or mixed episodes associated with bipolar I disorder.

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