Navigation Links
U.S. FDA Issues Complete Response Letter for SAPHRIS(TM) (ASENAPINE) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
Date:1/14/2009

Schering-Plough expects to respond to agency during first quarter

KENILWORTH, N.J., Jan. 14 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS(TM) (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. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

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.


'/>"/>
SOURCE Schering-Plough Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Issues a Complete Response Letter for Lillys Olanzapine LAI for Treatment of Schizophrenia in Adults
2. Coalition for 21st Century Medicine Issues Statement in Opposition of Genentech Petition to Restrict Lab Use of Diagnostic Tests for Physicians and Patients
3. MatTeks EpiDerm In Vitro Tissues Headed for Validation in Europe
4. Deer Farm Industry in Michigan Issues Statement on the Negative CWD Test Results at Kent County Deer Farm
5. U.S. FDA Issues Action Letter for Sugammadex
6. European CHMP Issues Positive Opinion on Cymbalta for the Treatment of Generalised Anxiety Disorder
7. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
8. Newly Published Study Shows OPKOs siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye
9. European Unions CHMP Issues Positive Opinion on Sugammadex
10. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
11. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... YORK , April 28, 2016 ... online consumer insights on healthcare, announced today that it ... their report Cool Vendor in Life Sciences, 2016, ... April 15, 2016.  The report focuses on life-science- oriented ... gain insight from patients and doctors, confirm medication ingestion, ...
(Date:4/28/2016)... 28, 2016   Acsis , a leading provider ... IT market research and advisory firm IDC has named ... MarketScape: Worldwide Pharmaceutical Track and Trace Software 2016 Vendor ... an assessment of the capabilities and business strategies of ... market. Logo - http://photos.prnewswire.com/prnh/20160427/360791LOGO ...
(Date:4/27/2016)... Inc. (Nasdaq: HOLX ) announced today ... quarter ended March 26, 2016.  GAAP diluted earnings ... non-GAAP diluted EPS of $0.47 increased 14.6%.  Revenue ... basis, and 6.3% on a constant currency basis.  ... highlighted by 14.6% growth in non-GAAP EPS," said ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... Memorial Healthcare ... Graduate Medical Education (ACGME) that it has received accreditation for its residency program ... three residency programs that Memorial is currently pursuing, including Pediatrics and Internal Medicine. ...
(Date:4/29/2016)... Calif. (PRWEB) , ... April 29, 2016 , ... Our ... An effective way to confront and deal with these stressors is to adopt a ... to be good for you. Risa Groux, a certified Holistic Nutritionist and the creator ...
(Date:4/29/2016)... ... April 29, 2016 , ... The American workforce is ... even security. Most importantly, employees are the single most important asset in creating ... so unhappy? , Just under half of American workers are emotionally checked out ...
(Date:4/29/2016)... ... April 29, 2016 , ... The White House announced efforts ... more information about their loan terms and accounts, and more protections for borrowers. ... federal and private loans, has reached $1.3 trillion, with 43 million Americans holding ...
(Date:4/29/2016)... ... April 29, 2016 , ... Coast Dental Fort Stewart is celebrating ... new location in the Exchange Furniture Mall at 112 Vilseck Road in Fort Stewart. ... Smart TV. Plus attendees will have the opportunity to meet general dentists Thomas Richards, ...
Breaking Medicine News(10 mins):