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One month turn around on Saphris

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Schering-Plough has responded to FDA regarding the NDA for Saphris (asenapine) sublingual tablets one month after receiving a "complete response" letter for the atypical antipsychotic, the firm announced Feb. 20. FDA had requested supplemental data from the existing database but did not ask for additional clinical trials for the drug, which is under review for acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder in adults as monotherapy (1"The Pink Sheet" DAILY, Jan. 14, 2009). The original action date for the NDA was in June
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