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:9/19/2014)... DALLAS , Sept. 19, 2014 /PRNewswire-iReach/ ... Chinese Oxybutynin Hydrochloride Industry, 2009-2019 is a ... and Chinese Oxybutynin Hydrochloride industry. The report ... Hydrochloride including its classification, application and manufacturing ... China,s top manufacturers of Oxybutynin Hydrochloride listing ...
(Date:9/19/2014)...  The board of directors of AbbVie Inc. (NYSE: ... of $0.42 per share.  The cash ... record at the close of business on Oct. 15, ... research-based biopharmaceutical company formed in 2013 following separation from ... dedicated people and unique approach to innovation to develop ...
(Date:9/19/2014)... -- Merck (NYSE: MRK ), known as MSD outside ... , is teaming with celebrity chef and cookbook author Leticia ... an educational program encouraging Hispanics with type 2 diabetes to achieve ... to help reduce the risk of serious health problems. Hispanics in ... risk for developing type 2 diabetes than non-Hispanic white adults, and ...
Breaking Medicine Technology:Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 2Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 3Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 4Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 5Celebrity Chef Leticia Moreinos Schwartz Partners with Merck on Desafiando La Diabetes: Logra Tus Metas to Urge Hispanics With Type 2 Diabetes to Get to Their A1C Goal 2Celebrity Chef Leticia Moreinos Schwartz Partners with Merck on Desafiando La Diabetes: Logra Tus Metas to Urge Hispanics With Type 2 Diabetes to Get to Their A1C Goal 3Celebrity Chef Leticia Moreinos Schwartz Partners with Merck on Desafiando La Diabetes: Logra Tus Metas to Urge Hispanics With Type 2 Diabetes to Get to Their A1C Goal 4Celebrity Chef Leticia Moreinos Schwartz Partners with Merck on Desafiando La Diabetes: Logra Tus Metas to Urge Hispanics With Type 2 Diabetes to Get to Their A1C Goal 5
... (vRad), a technology-enabled national radiology practice, announced ... Radiology Associates (MRA) have joined its Pennsylvania-based ... (DII). These former MRA radiologists will continue ... and join the more than 60 DII ...
... 2011  The Austen BioInnovation Institute in Akron (ABIA) ... today a strategic partnership to share expertise while ... The partnership combines the polymer ... of ABIA with Lubrizol, a key medical polymer ...
Cached Medicine Technology:vRad Radiology Alliance Continues to Transform Radiology With Most Recent Practice Partnership 2Austen BioInnovation Institute and Lubrizol Announce New Strategic Innovation Partnership 2Austen BioInnovation Institute and Lubrizol Announce New Strategic Innovation Partnership 3
(Date:9/21/2014)... 2014 Market Research Report ... Industry, 2009-2019 is a professional and in-depth ... (CAS 49562-28-9) industry. The report firstly reviews ... including its classification, application and manufacturing technology.The ... manufacturers of Fenofibrate (CAS 49562-28-9) listing their ...
(Date:9/21/2014)... “Cluster headaches are sometimes called ‘Suicide ... to resolve,” said Steve Young of Ew Publishing; “I’ve ... pain that is more intense.” , “It should be ... or migraines, that medical research is pointing to some ... added. , Serotonin (5-HT, 5-hydroxytryptamine) is a ubiquitous biochemical ...
(Date:9/21/2014)... According to latest National Vital Statistics ... since 1966 (10.5 births per 1,000 women in 2013). Since ... risen steadily by 2 percent per year. The birth rate ... 50 and over) also rose, the first such increase since ... nine times as many first births to women aged 35 ...
(Date:9/20/2014)... Vegas, NV (PRWEB) September 21, 2014 ... improvement method developed by fitness expert Michael Wren that ... lose stubborn weight and reverse health conditions like high ... the attention of Shane Michaels, prompting an investigative review. ... loss methods and tips upside down by showing people ...
(Date:9/20/2014)... September 21, 2014 Increases in ... to greater waste treatment volumes. However, government regulations ... waste from landfill. According to IBISWorld industry analyst ... implemented strategies aimed at reducing the volume of ... recycled and recovered.” Still, a large proportion of ...
Breaking Medicine News(10 mins):Health News:Fenofibrate Industry Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 2Health News:Fenofibrate Industry Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 3Health News:Fenofibrate Industry Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 4Health News:Homeostasis: Equinox Serotonin (5HT) Headache Stories ~ New on the Bryan William Brickner Blog 2Health News:Statistics Reveal That the Number of 'Older' First-Time Mothers Is Growing 2Health News:Statistics Reveal That the Number of 'Older' First-Time Mothers Is Growing 3Health News:Statistics Reveal That the Number of 'Older' First-Time Mothers Is Growing 4Health News:Weight Destroyer: Review Exposes Michael Wren’s Guide to Effective Weight Loss and Improved Health 2Health News:Weight Destroyer: Review Exposes Michael Wren’s Guide to Effective Weight Loss and Improved Health 3Health News:Waste Treatment and Disposal Services in Australia Industry Market Research Report Now Updated by IBISWorld 2Health News:Waste Treatment and Disposal Services in Australia Industry Market Research Report Now Updated by IBISWorld 3
... antibodies in migrant birds in five Siberian regions, a spokesman ... ,"Out of over 4,000 samples taken in the area this ... genetic material of the A-H5 virus and antibodies in their ... the presence of antibodies meant that either the birds had ...
... assess the effectiveness and tolerability of subdermal implantable contraceptives ... that they were all good at preventing pregnancy. ... be any more or less effective than the others ... effect with all the implants was changes in bleeding ...
... atrial fibrillation (AF) have irregular heart beats and have a ... (atria) of their hearts. These clots can then travel to ... ,One way of reducing the risk of this occurring is ... clots. Two commonly used options are anticoagulants that inhibit the ...
... smoking to secure peoples' rights to the highest standards of ... implementing a comprehensive anti-tobacco law to reduce the spread of ... Ali bin Shukur, Under-secretary of the Ministry of Health, was ... bill on smoking is being deliberated at the UAE Ministerial ...
... found in turmeric may help beat Alzheimer's, which is ... ,Researchers isolated the compound 'bisdemethoxycurcumin' found in turmeric, which ... the body against infections and diseases. ... patients and treat the incurable and fatal brain condition, ...
... six-month phase of a calorie-restriction study conducted at the ... Aging (USDA HNRCA) at Tufts University suggest that,accepting food ... important component of weight management. ,Supplemental results ... Restricting Intake of Energy (CALERIE) trial provide new insights ...
Cached Medicine News:Health News:Anticoagulants is Better for Atrial Fibrillation 2Health News:Food Cravings are Linked to Weight Managenemt 2Health News:Food Cravings are Linked to Weight Managenemt 3
Launcher Coronary Guide Catheter gives a dependable platform for optimal outcomes with absolute visualization and a proprietary design....
St. Jude Medical's line of guiding introducers includes Swartz Series, SAFL, SEPT, CSTA, RAMP, and 2 piece steerable...
... Fast-Cath, Maximum, Maximum Xtra, and ... line of standard and specialty hemostasis ... recognized as the premier hemostasis introducers ... electrophysiology procedures including angiography, angioplasty, stenting, ...
New system has all of the features of the EPT-1000TC. Now with 100 watts RF power using the Blazer II XP catheter....
Medicine Products: