Navigation Links
FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia
Date:7/30/2009

KENILWORTH, N.J., July 30 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of SAPHRIS(R) (asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of use in acute treatment of schizophrenia in adults. If approved by FDA, SAPHRIS would be the first psychotropic drug to be approved initially for both of these indications.

"We are very pleased with the outcome of today's advisory committee meeting and appreciate the panel's careful consideration of the efficacy and safety data for SAPHRIS," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "In clinical studies, SAPHRIS has demonstrated efficacy combined with an attractive metabolic safety profile. SAPHRIS has the potential to address a significant unmet need for patients with schizophrenia and bipolar I disorder, including patients starting treatment and those who need alternative treatment options when switching or re-initiating therapy. We will continue to work with FDA to bring SAPHRIS to the U.S. market as soon as possible so that patients can benefit from this new medication."

While the FDA is not bound by the committee's recommendations, the agency carefully considers them before making a final decision on approval. After reviewing the SAPHRIS data, the committee voted in favor of SAPHRIS as effective (by counts of 12/0/0 and 10/2/0, yes/no/abstain) and safe (12/0/0 and 10/0/2) for the bipolar I disorder and schizophrenia indications, respectively. In addition, the committee voted on the overall balance of safety and
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
2. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
3. Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid Arthritis
4. Schiffrin Barroway Topaz & Kessler, LLP and Janet Jenner & Suggs, LLC Comment on Conagra Advisory Regarding Pot Pies Linked to Salmonella Outbreak
5. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
6. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
7. HUYA Bioscience Intl Announces World-Class Clinical Advisory Team for New Anti-Arrhythmic Compound Sourced From China
8. FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. UBC Forms European Advisory Board to Enhance Data Quality of CNS Trials
11. FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/14/2014)... 14, 2014 /PRNewswire-iReach/ -- Harmony Foundation, Colorado,s ... Estes Park , will break ground for a new ... am on Harmony,s campus. The public is welcome to attend ... of Harmony,s $10 million Support & Renew Capital Campaign ... and complex addiction rates in Colorado . ...
(Date:7/14/2014)...  More than any other generation, Millennials born in the ... but their eyes don,t. These mobile devices demand a type ... eye has not evolved to cope with them. The gap ... comfortably often results in tired eyes, focusing problems, headaches and ... Now ZEISS has invented a new type of lens for ...
(Date:7/14/2014)...  GenSpera, Inc. (OTCQB: GNSZ), a leader in ... announces that Kareg Corporation,s Director of Research, ... research report on  the company. ... Kareg Corporation, Initiating Coverage with a Speculative Buy ... http://www.genspera.com/press/140711_Genspera_research_report_July2014.pdf GNSZ is attractive ...
Breaking Medicine Technology:Harmony Foundation Breaking Ground on Addiction Health Center 2New Eyeglass Lens Helps Our Eyes Keep Up with our Digital Lives 2New Eyeglass Lens Helps Our Eyes Keep Up with our Digital Lives 3Kareg Corporation Initiates Coverage on GenSpera with a Speculative Buy Recommendation 2Kareg Corporation Initiates Coverage on GenSpera with a Speculative Buy Recommendation 3Kareg Corporation Initiates Coverage on GenSpera with a Speculative Buy Recommendation 4Kareg Corporation Initiates Coverage on GenSpera with a Speculative Buy Recommendation 5Kareg Corporation Initiates Coverage on GenSpera with a Speculative Buy Recommendation 6
(Date:7/14/2014)... Academy, senescent is he who "begins to age". But ... is senescence not a synonym of ageing, it is ... is such a badly named physiological process that those ... another name. That is the case of Manuel Serrano, ... of the world,s leading experts on senescence, who has ...
(Date:7/14/2014)... (PRWEB) July 14, 2014 The ... & Services [Physical Security, Life Safety, Facility Management], ... Worldwide Forecast & Analysis (2014 - 2019)” defines ... with an in-depth analysis and forecasting of revenues. ... market, various restraints and opportunities impacting it, along ...
(Date:7/14/2014)... into an agreement with one of the world,s ... candidates for the detection and treatment of cancer. ... antibody discovery and Roche,s expertise in developing monoclonal ... of improved treatment for cancer, a leading cause ... use of BTI,s discovery of a new mechanism ...
(Date:7/14/2014)... Secure Decisions, a leading provider of assessment ... Software Assurance Marketplace (SWAMP) to build a powerful and ... everyday life. , The SWAMP, implemented by a group ... Institute for Research, is funded by the Department of ... by building a free facility with a diverse repository ...
(Date:7/14/2014)... with improving vision, cataract surgery may slow mental decline ... dementia, a new study suggests. Better eyesight also ... "These preliminary results indicate that improved vision can have ... their loved ones, both visual and non-visual," said Dr. ... Hospitals Case Medical Center, in Ohio. Cataract surgery ...
Breaking Medicine News(10 mins):Health News:Manuel Serrano proposes a new vision of a process wrongly associated with ageing 2Health News:Manuel Serrano proposes a new vision of a process wrongly associated with ageing 3Health News:Intelligent Building Automation Technologies Market Worth $74.8 Billion by 2019 - New Report by MarketsandMarkets 2Health News:Intelligent Building Automation Technologies Market Worth $74.8 Billion by 2019 - New Report by MarketsandMarkets 3Health News:Intelligent Building Automation Technologies Market Worth $74.8 Billion by 2019 - New Report by MarketsandMarkets 4Health News:A*STAR partners Roche to develop new cancer therapeutics 2Health News:Madison-based SWAMP, Secure Decisions partner to enhance software security 2Health News:Madison-based SWAMP, Secure Decisions partner to enhance software security 3Health News:Cataract Surgery a Plus for Someone With Dementia, Study Says 2
... , Preliminary research on Fusarium , a group ... animals, shows how these microbes travel through the air. ... preliminary research, there will be a better understanding about ... biologists are steering their efforts towards a new aerobiological ...
... malaria vaccine that uses the entire malaria parasite has proven ... in a clinical trial, according to a new study co-authored ... Center for Vaccine Development. The vaccine is unique in that ... vaccines consist of just one or at most a few ...
... Institute in Boston and the Scripps Research Institute in ... powerful anti-diabetic effects, yet apparently free at least ... current diabetes medications. The researchers say that their ... 2 diabetes, which affects more than 25 million children ...
... HealthDay Reporter , FRIDAY, Sept. 9 (HealthDay News) -- ... were to meet Friday to discuss problems linked to ... Boniva and Reclast. These drugs, known as ... osteoporosis. But researchers have linked long-term use with a ...
... HealthDay Reporter , THURSDAY, Sept. 8 (HealthDay News) -- Many ... infant. But sometimes that concern develops into an obsession over ... that condition postpartum obsessive compulsive disorder. It can drive women ... true, such as endlessly washing the infant to stave off ...
... at the University of Ottawa Heart Institute (UOHI) have ... and exports cholesterol from cells. A team ... Biology Laboratory, UOHI, has shown that autophagy, a pathway ... accumulated in artery walls. This process facilitates the removal ...
Cached Medicine News:Health News:Microbes travel through the air; it would be good to know how and where 2Health News:Microbes travel through the air; it would be good to know how and where 3Health News:Whole-parasite malaria vaccine shows promise in University of Maryland School of Medicine clinical trial 2Health News:Whole-parasite malaria vaccine shows promise in University of Maryland School of Medicine clinical trial 3Health News:Whole-parasite malaria vaccine shows promise in University of Maryland School of Medicine clinical trial 4Health News:Whole-parasite malaria vaccine shows promise in University of Maryland School of Medicine clinical trial 5Health News:New twist in diabetes drugs could reduce life-threatening side effects 2Health News:New twist in diabetes drugs could reduce life-threatening side effects 3Health News:Osteoporosis Drugs' Safety Subject of FDA Panel 2Health News:Osteoporosis Drugs' Safety Subject of FDA Panel 3Health News:When Protecting Baby Becomes an Obsession 2Health News:When Protecting Baby Becomes an Obsession 3Health News:Researchers find process that clears cholesterol and could reverse major cause of heart attack 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: