Navigation Links
U.S. FDA Issues Action Letter for Sugammadex
Date:8/1/2008

KENILWORTH, N.J., Aug. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the reversal of muscle relaxation during general anesthesia.

"We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March of this year," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "Sugammadex represents the first major pharmaceutical innovation in the field of anesthesia in two decades. We remain committed to bringing this important medical advance to those who are waiting for it in the United States, and plan to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions." There were no issues related to the efficacy of sugammadex.

Schering-Plough acquired sugammadex in November 2007 through its acquisition of Organon BioSciences, which developed the product.

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 and consumer products as well as to animal health 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.,
'/>"/>

SOURCE Schering-Plough Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
2. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
3. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
4. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
5. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
6. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
8. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
9. European Unions CHMP Issues Positive Opinion on Sugammadex
10. Newly Published Study Shows OPKOs siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye
11. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... Dec. 18, 2014   Aratana Therapeutics, Inc ... company focused on the licensing, development and commercialization ... positive results from its pivotal field study of ... pain in dogs with osteoarthritis.  In the study, ... scores that were statistically significant compared to placebo ...
(Date:12/19/2014)... development with the growth pace keeping at 20%-30% in last ... size of China separating membrane products ... 16.3%. It is projected that China ... 20% in the upcoming years and that the figure by ... integrated membrane industrial system has taken shape in ...
(Date:12/17/2014)... Los beneficios y ganancias están ... de gasto en investigación y desarrollo   ... de septiembre de 2014) ZEISS aumentó sus ingresos en ... (año anterior: 4.190 millones de euros) a pesar de ... crecieron un 14 por ciento, a 360 millones de ...
Breaking Medicine Technology:Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 2Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 3Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 4Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 5Separation Membranes Market (Company, Country & Application) Research Reports for Global and Chinese Regions 2Separation Membranes Market (Company, Country & Application) Research Reports for Global and Chinese Regions 3ZEISS confirma su posición en un entorno difícil 2
(Date:12/21/2014)... York (PRWEB) December 21, 2014 ... other product liability claims involving a class of ... continue to move forward in a federal multidistrict ... District of California, Bernstein Liebhard LLP reports. According ... has established a data cut-off date of February ...
(Date:12/21/2014)... AlignLife of Norton Shores is spreading Christmas ... time helping people get their health back. Mission for ... serving those persons in Muskegon County who are unable to ... of life. Dr. Michael Rykse wanted to do a Toy ... and he knew he found that when he heard what ...
(Date:12/21/2014)... Portland, OR (PRWEB) December 21, 2014 ... discussing some of the issues and systemic barriers for ... ITU World Paratriathlon Champion. Scheidies has a condition called ... over time. He describes how he adapted his athletic ... to use his success in triathlon to pioneer the ...
(Date:12/21/2014)... The Oncology Institute of Hope and Innovation hosted their ... offices. The Hope for the Holidays Toy Drive is a ... families during the holiday season. This year, the toy drive ... both offices. This event continues to be successful year after ... store managers and assistant managers came out and not only ...
(Date:12/20/2014)... a distinguished special dress supplier, has just done something ... cut prices to all its prom dresses already, offering ... Many of the hottest styles are sold here like ... more. , A spokesman for MissyDress says, “The great ... prom dresses or sweetheart chiffon prom dresses, you will ...
Breaking Medicine News(10 mins):Health News:Byetta Lawsuit News: New Order Issued in Federal Incretin Mimetics Litigation, Bernstein Liebhard LLP Report 2Health News:Byetta Lawsuit News: New Order Issued in Federal Incretin Mimetics Litigation, Bernstein Liebhard LLP Report 3Health News:Byetta Lawsuit News: New Order Issued in Federal Incretin Mimetics Litigation, Bernstein Liebhard LLP Report 4Health News:AlignLife of Norton Shores Makes a Brighter Christmas for Kids in Muskegon 2Health News:Disability in Sports on SCI TV with Triathlon World Champ Aaron Scheidies 2Health News:Disability in Sports on SCI TV with Triathlon World Champ Aaron Scheidies 3Health News:MissyDress: The Prices of Prom Dresses Just Reduced 2
... dental plan services for members, ROCKVILLE, Md., ... provider of comprehensive dental plans and administration, has,announced ... of the,nation,s leading integrated health plan provider. GDS ... access and,call center support to Kaiser Permanente Northwest,s ...
... new study by a NewYork-Presbyterian Hospital/Weill Cornell Medical Center ... not too late to improve your health through diet ... in the past! , Published in the November issue ... surveyed scientific literature and found that adults, 65 and ...
... In addition to allowing us to see, the mammalian eye ... prime example of this is the timing of the sleep/wake ... the circadian pacemaker in the hypothalamus. , In a ... have identified two totally blind humans whose non-visual responses to ...
... Centers for Disease,Control and Prevention (CDC), with ... Infection Control and Epidemiology (APIC), is,developing a ... data from existing commercial,software systems to the ... solution enables hospitals to provide data already,collected ...
... Long-term care insurer,MedAmerica, will expand with a new ... Company of Florida (Home Office: Winter Park, FL).,Recognizing ... market,MedAmerica decided to incorporate a new carrier dedicated ... mark the launch of MedAmerica,s cash long term,care ...
... marked cut-off for fertility, researchers say , THURSDAY, Dec. 13 ... chimpanzees go through menopause in the way that human females ... taper off at a similar age. , "When we look ... be reproducing better than humans in their forties," researcher Melissa ...
Cached Medicine News:Health News:Message to the elderly: It's never too late to prevent illness! 2Health News:Blind humans lacking rods and cones retain normal responses to non-visual effects of light 2Health News:Blind humans lacking rods and cones retain normal responses to non-visual effects of light 3Health News:CDC Uses New Technical Approach to Enable Hospital Reporting of Healthcare-Associated Infections 2Health News:New Long-Term Care Insurer Offers Simplified Insurance Plans in Florida 2Health News:Menopause May Be Unique to Humans 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: