FDA to Review Schering-Plough’s Asenapine NDA
November 27, 2007
The FDA has accepted Schering-Plough’s new drug application for asenapine, a fast-dissolving, sublingual tablet for schizophrenia, for review.
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 new drug application (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.