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.