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Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA
Date:11/25/2007


KENILWORTH, N.J., Nov. 26 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) recently accepted the filing for review of the New Drug Application (NDA) for asenapine, a fast-dissolving, sublingual tablet. Schering-Plough is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes associated with Bipolar I Disorder. In accepting the NDA, the FDA indicated that asenapine will receive a standard review.

The clinical trial program thus far has consisted of schizophrenia and bipolar mania trials involving nearly 3,000 patients.

Schering-Plough acquired asenapine through its combination with Organon BioSciences on November 19, 2007.

About Bipolar Disorder

Bipolar Disorder, commonly referred to as manic-depressive disorder, is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both. It affects approximately one to five percent of adults, including more than 10 million adults in the United States and more than four million people in Europe. (1,2,3) The condition can start early in childhood or later in life, the average age of onset is between 15 and 25 years old.(4) Bipolar Disorder is the sixth leading cause of disability in the world.(2) About half of the patients with Bipolar Disorder who recover in response to treatment experience recurrence two years later(5).

About schizophrenia

Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusio
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SOURCE Schering-Plough Corporation
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