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Schering-Plough Submits Response to FDA for SAPHRIS(TM) (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
Date:2/20/2009

Response submitted within one month of FDA complete response letter

KENILWORTH, N.J., Feb. 20 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that it has responded to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS(TM) (asenapine) sublingual tablets, which was received in January 2009. SAPHRIS is under review for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

The action letter included proposed labeling for both indications and a request for supplemental data from the existing asenapine database. No additional clinical trials were requested.

"We are pleased to have submitted the SAPHRIS complete response within a month from receipt of the FDA action letter. We look forward to working with the agency to finalize labeling and gain approval, and to bringing a new therapy to patients with schizophrenia and bipolar I disorder," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute.

Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the antipsychotic agent. The New Drug Application (NDA) for asenapine includes data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care
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SOURCE Schering-Plough Corporation
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