Navigation Links
FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
Date:3/11/2008

g-Plough announced that the FDA assigned priority review status to the company's New Drug Application (NDA) for sugammadex. In the U.S., priority review is granted to drugs that FDA believes will provide meaningful benefit over existing treatment options.

Sugammadex is specifically designed to reverse the effects of certain widely used muscle relaxants, marketed in the United States as ZEMURON(R) (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. Sugammadex works in an entirely novel way to encapsulate the muscle relaxant molecule and restore muscle function so that patients can breathe on their own again. Reversal with sugammadex is generally rapid and can even be used in emergency situations when immediate reversal of rocuronium is needed.

Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.

About Sugammadex

Sugammadex is a novel selective relaxant binding agent (SRBA) under development by Organon, a part of Schering-Plough Corporation. Sugammadex was designed to reverse the effects of rocuronium bromide (ZEMURON/ESMERON(R)/ESLAX(R)) or vecuronium bromide, muscle relaxants commonly used during surgeries that require profound muscle relaxation. Anesthesiologists use muscle relaxation to improve surgical conditions, to facilitate intubation and mechanical ventilation, and to reduce the chance of complications.

In clinical trials to date, sugammadex has demonstrated the ability to rapidly reverse shallow and profound depths of rocuronium-induced muscle relaxation, thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs(1). Sugammadex also has demonstrated the ability to reverse the effects of muscle relaxation induced by vecuronium bromide. The most common adverse reactions (incidence >5%) seen with sugammadex in clinical trials were anesthetic compli
'/>"/>

SOURCE Schering-Plough
Copyright©2008 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. Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
9. IDM Pharma Announces Non-Binding Opinion of the European Committee for Medicinal Products for Human Use (CHMP) that Mifamurtide (L-MTP-PE) Provides a Possible Clinical Benefit in Survival
10. CHMP Recommends Expanded Use of Angiox(R) (Bivalirudin) in Europe for Patients With Acute Coronary Syndromes
11. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R) Following Second Interim Review
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... SANTA BARBARA, Calif. , Dec. 23, 2014 ... the Junior Doctors, Association of Sierra Leone ... Sierra Leone for the treatment of local ... While a new dedicated Ebola care center was ... Ebola virus, the facility is not available for local Sierra ...
(Date:12/22/2014)... , Dec. 22, 2014  CytoSorbents Corporation (OTCQB:CTSOD), ... CytoSorb® blood purification technology to help fight deadly ... 28 countries worldwide, today announced the appointment of ... FACS, as its Senior Vice President of Clinical ... Dr. Di Russo is an accomplished ...
(Date:12/22/2014)... and Markets ( http://www.researchandmarkets.com/research/h3xm6q/us ) has announced ... Market" report to their offering. ... focuses on the developments in the self-monitoring blood glucose ... Reimbursement analysis and the effects of competitive bidding have ... SMBG meters have been performed, based on the various ...
Breaking Medicine Technology:First Ebola Treatment Unit for Local Health Workers Arrives in Sierra Leone 2CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 2CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 3CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 4CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 5US Self-monitoring Blood Glucose Market 2
... Sheets: SIMH)  In a shrewd execution of its business ... with Keith Houlihan, Co-founder and President of Sanomedics ... signing of a letter of intent to acquire a ... platform in sleep apnea treatment services.  The targeted acquisition ...
... Dec. 12, 2011  Inovio Pharmaceuticals, Inc. (NYSE Amex: ... and infectious diseases, announced today that Dr. J. Joseph Kim, ... at the Oppenheimer 22nd Annual Healthcare Conference taking place December ... Inovio Presentation December 13 10:50 am ET ...
Cached Medicine Technology:Sanomedics Signs Letter of Intent to Acquire Large Sleep Disorder Service Based Operation 2Inovio Pharmaceuticals to Present at Oppenheimer Investor Conference 2Inovio Pharmaceuticals to Present at Oppenheimer Investor Conference 3
(Date:12/24/2014)... a famous bamboo flooring company offering bamboo flooring products ... its multiple layer bamboo panel board collection , and ... Bamboo panel is the product made from 100 percent ... features high quality selective bamboo and eco-friendly adhesives that ... consists of multiple layers of bamboo. , According to ...
(Date:12/24/2014)... -- The holidays can be a challenge for people who ... and drinks. "This is the season in which many ... Dr. David Dodick, chair of the American Migraine Foundation, said ... to think through food and beverage choices, to help reduce ... professor of neurology at the Mayo Clinic in Scottsdale, Ariz. ...
(Date:12/24/2014)... News) -- A new, injectable weight-loss drug has been ... The agency on Tuesday approved Saxenda (liraglutide) for adults ... and have at least one weight-related health condition, such ... cholesterol. Patients taking the drug, made by Novo ... regularly, the FDA noted. "Obesity is a public ...
(Date:12/24/2014)... WEDNESDAY, Dec. 24, 2014 (HealthDay News) -- Researchers say ... cells that develop into eggs and sperm. While ... this is the first time that these types of ... produced efficiently using human stem cells, according to the ... "The creation of primordial germ cells is one of ...
(Date:12/24/2014)... -- A lab technician with the U.S. Centers for ... the Ebola virus in an agency laboratory in Atlanta ... other lab workers are being checked for possible exposure, ... exposure occurred Monday when CDC scientists doing research on ... virus to another CDC lab in the same building, ...
Breaking Medicine News(10 mins):Health News:Bamboo Flooring Company Bambooindustry.com Introduces Its Multiple Layer Bamboo Panel Board Collection 2Health News:Expert Offers Tips for Preventing Holiday Migraines 2Health News:FDA Approves New Weight-Loss Drug 2Health News:FDA Approves New Weight-Loss Drug 3Health News:CDC Monitors Lab Worker for Possible Ebola Exposure 2
... MONDAY, Dec. 5 (HealthDay News) -- There,s been a large increase ... States since 2002, a trend that may help ease concerns about ... analyzed national data and found that the number of RNs aged ... fell to fewer than 110,000 by 1991 and remained low for ...
... University of Kentucky researchers recently received a $225,000 grant ... The grant gives the team $225,000 for the ... that could total $675,000. It is funded by the ... Rural Cancer Prevention Center. Published studies have shown ...
... By Serena Gordon HealthDay Reporter , MONDAY, Dec. ... with asthma is currently using a preventive medication, according to ... percent of kids during the late 1980s. Preventive ... up, and guidelines from the U.S. National Asthma Education and ...
... -- Teenagers with autism who also have epilepsy often ... The combination means that certain behaviors common among autistic ... of their faces -- could increase their risk for ... 14 percent of children with epilepsy, the rate jumps ...
... and non-obese children found that low vitamin D levels are ... risk factors for type 2 diabetes. This study was accepted ... Endocrinology & Metabolism (JCEM). High rates of vitamin ... studies have linked low vitamin D levels to cardiovascular disease ...
... , SATURDAY, Dec. 3 (HealthDay News) -- Seizures ... during menstruation or ovulation, researchers have found. ... at the University of California, Irvine, examined the trend ... among a group of women aged 19 to 50. ...
Cached Medicine News:Health News:Good News for Those Worried About U.S. Nursing Shortage 2Health News:University of Kentucky researchers awarded CDC grant to study cancer survival in Appalachia 2Health News:More Children Using Preventive Asthma Drugs: Study 2Health News:More Children Using Preventive Asthma Drugs: Study 3Health News:Low vitamin D levels may contribute to development of Type 2 diabetes 2Health News:Epileptic Seizures May Worsen During Menstrual Cycle 2
... Cutter has application in multiple open or ... resection, and/or creation of anastomoses and can ... buttressing materials such as bovine pericardium., ... a total of eight firings. Different cartridges ...
... in Open Procedures with Compact Endoscopic ... Compact-Flex45 No-Knife Articulating Linear Staplers is ... line for open surgical procedures. It ... blue cartridge, a thick-tissue green cartridge, ...
... ENDO CLIP MultApplier reusable clip applier is designed ... loading unit, each of which contains eight (8) ... shaft of the instrument is approximately 12.8" (32.5 ... and use through an appropriately sized Auto Suture ...
ENDO CLIP II ML, 10 mm Pistol Grip Single Use Clip Applier with Medium - Large Super Interlock Titanium Clips...
Medicine Products: