Schering-Plough asenapine submission accepted by FDA

KENILWORTH, N.J. The Food and Drug Administration has accepted Schering-Plough’s submission for a new drug application for the sublingual tablet asenapine, according to

The drug is used for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder. The clinical trial program for the drug has so far consisted of schizophrenia and bipolar mania trials involving nearly 3,000 patients. 

Schering-Plough recently acquired asenapine, when the company completed its buyout of Organon BioSciences.

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