Navigation Links
Schering-Plough Submits Response to FDA for SAPHRIS(TM) (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

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 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. The company is based in Kenilworth, N.J., and its Web site is

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 clinical development of, the commercial plans for and the potential market for SAPHRIS. 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.

SOURCE Schering-Plough Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Schering-Plough to Webcast Presentation at 27th Annual J.P. Morgan Healthcare Conference
2. HUYA Bioscience Announces Agreement to Provide Schering-Plough With Drug Development Candidates From China
3. Schering-Plough Declares Quarterly Dividends on Common Shares and 2007 Mandatory Convertible Preferred Stock
4. Schering-Plough Reschedules Time of Conference Call, Webcast for 2008 Second Quarter Earnings to Later Today
5. Schering-Plough Announces Closing of Planned Divestiture of Selected Animal Health Products
6. Schering-Plough Declares Quarterly Dividends on Common Shares and 2007 Mandatory Convertible Preferred Stock
7. Schering-Plough Schedules Conference Call and Webcast for 2008 Second Quarter Earnings
8. Schering-Plough Appoints Janet M. Barth Vice President, Investor Relations
9. Schering-Plough Schedules Webcast for Annual Meeting of Shareholders
10. Intervet/Schering-Plough Animal Health Outlines Strength of the Combination
11. Schering-Plough/MERCK Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast
Post Your Comments:
(Date:6/27/2016)... ... 2016 , ... Cancer experts from Austria, Hungary, Switzerland, and ... new and helpful biomarker for malignant pleural mesothelioma. Surviving Mesothelioma has just published ... , Biomarkers are components in the blood, tissue or body fluids that ...
(Date:6/27/2016)... ... June 27, 2016 , ... Newly ... technologies, services and solutions to the healthcare market. The company's primary focus is ... manufacturing, sales and marketing strategies that are necessary to help companies efficiently bring ...
(Date:6/27/2016)... , June 27, 2016  Liquid Biotech ... announced the funding of a Sponsored Research Agreement ... circulating tumor cells (CTCs) from cancer patients.  The ... in CTC levels correlate with clinical outcomes in ... These data will then be employed to support ...
(Date:6/24/2016)... , June 24, 2016  Regular discussions on a ... take place between the two entities said Poloz. ... Ottawa , he pointed to the country,s ... the federal government. ... said, "Both institutions have common economic goals, why not sit ...
Breaking Biology Technology:
(Date:3/31/2016)... March 31, 2016   ... or the "Company") LegacyXChange is excited to ... its soon to be launched online site for trading ... ) will also provide potential shareholders a sense ... technology to an industry that is notorious for fraud. ...
(Date:3/23/2016)... March 23, 2016 ... Sicherheit Gesichts- und Stimmerkennung mit Passwörtern ... (NASDAQ: MESG ), ein führender Anbieter ... Unternehmen mit SpeechPro zusammenarbeitet, um erstmals dessen ... wird die Möglichkeit angeboten, im Rahmen mobiler ...
(Date:3/21/2016)... Unique technology combines v ... security   Xura, Inc. ... digital communications services, today announced it is working alongside ... customers, particularly those in the Financial Services Sector, the ... within a mobile app, alongside, and in combination with, ...
Breaking Biology News(10 mins):