FDA requests more existing data on S-P's Saphris before approval
The US Food and Drug Administration has asked to see extra data on Schering-Plough's Saphris (asenapine) before granting its approval for schizophrenia and manic or mixed episodes associated with bipolar I disorder. The FDA action letter requests data from the existing asenapine database but does not require new trials to be carried out. S-P expects to submit the data in first-quarter 2009.
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