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FDA accepts asenapine for NDA filing review


Schering-Plough has announced that the US Food and Drug Administration has accepted the filing for review of the New Drug Application (NDA) for asenapine, a fast-dissolving, sublingual tablet.

The company is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes associated with Bipolar Disorder.

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In accepting the NDA, the FDA indicated that asenapine would receive a standard review.

The clinical trial programme 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 last week.


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