Navigation Links
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
'/>"/>

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

Page: 1 2

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:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... 15, 2014 TaiGen Biotechnology Company, Limited ("TaiGen") today ... R-Pharm, a leading Russian pharmaceutical company, to develop and ... Russian Federation , Turkey ... is a novel antibiotic for the treatment of bacterial ...
(Date:1/14/2014)... Carahsoft and CDS Federal Services have scheduled a ... EST (11am PST), “Natural Language Processing: Converting Raw Data ... can turn raw, heterogeneous data into actionable knowledge to ... webinar will last approximately one hour. , Synopsis: Big ...
(Date:1/14/2014)... , Jan. 14, 2014  3D Communications, a leading provider of strategic ... business, and media events in the United States ... associate Virginia Cox , JD, is returning to the firm,s ... Cox re-joins 3D after more than two years of service ...
(Date:1/14/2014)... 2014 EquitiesIQ, a leading informational research ... Alliqua is an emerging biomedical company acquiring, developing, manufacturing, ... market. , Free report download: http://equitiesiq.com/reports/alliqua/ , ... management team and Board, which launched the company’s new ...
Breaking Biology Technology:TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 2TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 3TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 4Webcast - Natural Language Processing: Converting Raw Data into Actionable Knowledge – Hosted by Carahsoft and CDS Federal Services 2Former FDA Associate Commissioner Returns To 3D Communications 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 3
... ... , ... Waterville, ME (Vocus) April 15, 2010 -- Cerealus Holdings, in collaboration with the ... Next Generation Strength + Retention System.” Originally patented by DuPont and later developed ...
... ... attendance at the Partec/Powtech/WCPT6 on April 26-29 in Nuremberg, Germany. Visit ... range including FBRM® C35, PVM® V819, and S400 laboratory probes. In ... three posters and one paper. FBRM® and PVM® technology will also ...
... ... reporting and ad hoc analysis , ... (PRWEB) April 13, 2010 -- Like many customer-oriented organizations, Maine Medical ... its data. The program manages behavioral healthcare for 69,000 recipients in Maine, New ...
Cached Biology Technology:Cerealus Announces Licensing Agreement for Bio-Based Ceregel™, A Next Generation Strength and Retention System 2Track Particle Distribution in Real Time 2Track Particle Distribution in Real Time 3Maine Medical Center Chooses Business Intelligence Solution from Rapid Insight Inc. 2
(Date:4/17/2014)... a novel method to help kidney stone sufferers ... treatment possible., Kidney stones represent a major medical ... left untreated, apart from being particularly painful, they ... In many patients treated successfully, stone recurrence is ... approach to diagnosis and treatment needs to be ...
(Date:4/17/2014)... whereby the genetic information of DNA is used ... have numerous different functions in living organisms. Messenger ... gene expression, by relating the genetic information of ... proteins. , By examining the different types ... organism at a given time, researchers can determine ...
(Date:4/17/2014)... View of Domestication," a special feature of The ... ( PNAS ) published April 29, raises a ... deep history that most of us take for granted. ... in many spots around the globe shifted from hunting ... and plants. , It seems so straightforward and yet ...
Breaking Biology News(10 mins):Rapid and accurate mRNA detection in plant tissues 2Genetic study tackles mystery of slow plant domestications 2Genetic study tackles mystery of slow plant domestications 3Genetic study tackles mystery of slow plant domestications 4
... NYJuly 28, 2011A new study co-authored by Columbia Engineering ... Environmental Science & Technology , shows that reducing ... with "sizable" economic benefits, as well as the expected ... five scientists from around the U.S. who worked on ...
... -- (July 28, 2011) -- The DNA evidence is in, ... more than 1,000 Chinese tallow trees from the United States ... the tallow trees that are overrunning thousands of acres of ... widely known that Franklin introduced tallow trees to the U.S. ...
... the Food and Drug Administration approved a drug called ... African-American patients, claiming in a press release that this ... Invention: How Science, Politics and Big Business Re-create Race ... Roberts, the Kirkland & Ellis Professor at Northwestern University ...
Cached Biology News:New study outlines economic and environmental benefits to reducing nitrogen pollution 2New study outlines economic and environmental benefits to reducing nitrogen pollution 3Genetic evidence clears Ben Franklin 2Genetic evidence clears Ben Franklin 3Divided by race 2
Mouse monoclonal antibody raised against a full length recombinant CSNK2A2. NCBI Entrez Gene ID = CSNK2A2...
... DNA Visualizer Extraction Kit is manufactured ... causing DNA damage byexposure to UV light. ... gel is often used for DNA-cloning work. ... ethidium bromide and exposure of UV light ...
... Mouse monoclonal antibody raised against a partial ... (AAH39825, 358 a.a. ~ 457 a.a) partial recombinant ... Sequence: PPKQQSQEKPPQTLFPSIVKNMPTKPNGTLSHKSGRRRWGQTIFKSGDSWEELEDYDFGASHSKKPSMGVFKEKRKKDSPFRQQVKMAVISLSAHQFPTL Accession: ... AAH39825 OMIM: 154235, ...
Mouse monoclonal antibody raised against a partial recombinant L3MBTL2. NCBI Entrez Gene ID = L3MBTL2...
Biology Products: