Generic name: asenapine
Treatment for: Schizophrenia, Bipolar Disorder
FDA Issues Complete Response Letter for Saphris
FDA Issues Complete Response Letter for Saphris for Acute Treatment of Both Schizophrenia and Bipolar I Disorder
Schering-Plough expects to respond to agency during first quarter
KENILWORTH, N.J., January 14, 2009 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for Saphris (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy. The action letter includes proposed labeling for both indications and a request for supplemental data from the existing asenapine database. No additional clinical trials have been requested. The Company anticipates providing the requested information to the agency in the first quarter of 2009.
"We are pleased with the progress on the Saphris filing and look forward to working with the agency to address its request, finalize the product labeling and gain approval," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "New treatments are needed in this therapeutic area and we believe that asenapine has the potential to be an important option in addressing this need."
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 products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the plans for, the potential of and the potential market for asenapine. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including uncertainties in the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A. "Risk Factors" in the third quarter 2008 10-Q, filed Oct. 29, 2008.
Posted: January 2009
- Actavis Receives FDA Approval of Saphris for Pediatric Patients with Bipolar I Disorder - March 13, 2015
- Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets - September 7, 2010
- Schering-Plough Announces FDA Approval of Saphris (asenapine) - August 14, 2009
- FDA Advisory Committee Votes in Favor of Saphris (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia - July 30, 2009
- Schering-Plough Submits Response to FDA for Saphris (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder - February 20, 2009
- Schering-Plough Announces Asenapine NDA Accepted for Filing by theU.S. FDA - November 26, 2007
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