Home » FDA Accepts Asenapine Filing
FDA Accepts Asenapine Filing
The FDA has accepted Schering-Plough’s new drug application for asenapine, a treatment for schizophrenia and acute mania or mixed episodes associated with bipolar 1 disorder.
The clinical program consisted of schizophrenia and bipolar mania trials involving approximately 3,000 patients, Schering-Plough said.
Schering-Plough acquired asenapine through its combination with Organon BioSciences Nov. 19.
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