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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.

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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