Resources for Food and Drug Administration (FDA)

FDA to review Schering-Plough's asenapine NDA

www.pharmaceutical-business-review.com

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.

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