Navigation Links
European Commission and United States Food and Drug Administration (FDA) Both Approve New Options for Patients With Certain Primary Brain Tumors
Date:3/5/2009

Schering-Plough Receives EU and US Approvals for Intravenous Formulation of Temozolomide As Well As EU Approval for Oral Temozolomide Sachet Presentation

KENILWORTH, N.J., March 5 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug. Temozolomide is marketed as TEMODAL(R) in the EU and as TEMODAR(R) in the US. The EU Commission Decision was based on the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in November 2008. On January 22, 2009, the Commission approved a sachet packaging presentation for TEMODAL Capsules. This new presentation provides greater patient convenience and flexibility. On February 17, 2009, the Commission approved an IV formulation of TEMODAL. On February 27, 2009, Schering-Plough received approval from the US FDA for the TEMODAR IV formulation.

TEMODAL is a chemotherapy agent approved in the EU for treatment of patients with newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy, and for patients with malignant gliomas, such as GBM or anaplastic astrocytoma (AA), showing recurrence or progression after standard therapy. In the US, TEMODAR is approved for the treatment of adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment, as well as for refractory AA, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

"TEMODAR is a well recognized, effective treatment for patients with newly diagnosed GBM. The newly approved IV formulation of TEMODAR provides
'/>"/>

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

Page: 1 2 3 4 5 6 7

Related medicine news :

1. CorMatrix Cardiovascular Announces First European Implants of CorMatrix(R) ECM Technology(TM)
2. Winner Medical Receives European Patent Office Approval for PurCotton(TM) Production Method
3. Frost & Sullivan: Novel Diagnostics Methods Driving the European Cancer IVD Market Towards Early Detection and Prevention
4. Abbott Receives European Commission Clearance on Acquisition of Advanced Medical Optics
5. Eisai and Bial Announce Partnership Agreement for the European Commercialisation of the Novel Once Daily Anti-Epileptic Zebinix(R)
6. Rising Demand and Government Backing Fuel European Document Management Systems Market
7. Noteworthy Medical Systems, Inc. Secures Capital from Top European eHealth Provider and Closes on Merger with Strategic Partner
8. ECO 2009 -- The 17th European Congress on obesity
9. PAREXEL Consulting Enhances European Regulatory Affairs Capabilities With Appointment of Medical Products Agency Expert Dr. Anders Neil
10. Global Economic Meltdown - Is the European Cardiac Rhythm Management Market Spared?
11. BeneChill Launches European Study of Intra-Arrest Cooling
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... ... 2015 , ... Catalent Pharma Solutions, the leading global provider ... products, today welcomed the announcement by OPKO Health that the US Food and ... treatment for chronic kidney disease (CKD) and vitamin D insufficiency, which uses Catalent’s ...
(Date:8/3/2015)... Angeles, CA (PRWEB) , ... August 03, 2015 , ... ... dental services to help patients in need. Most people know that general health emergencies, ... emergency. Unfortunately, a fewer amount of people know where to turn to during a ...
(Date:8/3/2015)... ... August 03, 2015 , ... ... industry-defining contract lifecycle management solution, as well as announced the date of its ... speed and ease of contract management tasks as well as enhancements to the ...
(Date:8/3/2015)... (PRWEB) , ... August 03, 2015 , ... ... Physician Leadership ® and Navigant Center for Healthcare Research and Policy Analysis show ... Fifty-five percent of respondents said they agreed or strongly agreed that the controversial ...
(Date:8/3/2015)... ... August 03, 2015 , ... Sensato and ... Secure Healthcare Systems” This three-day, highly interactive and immersive workshop, has been ... access to the tactics, techniques and practices required to design and develop highly ...
Breaking Medicine News(10 mins):Health News:Catalent’s OptiShell™ Technology is Delivery Platform for OPKO Health’s New Chronic Kidney Disease Treatment 2Health News:Catalent’s OptiShell™ Technology is Delivery Platform for OPKO Health’s New Chronic Kidney Disease Treatment 3Health News:Los Angeles Dental Practice, Sunset Plaza Dental, Now Offers Emergency Dental Services 2Health News:Los Angeles Dental Practice, Sunset Plaza Dental, Now Offers Emergency Dental Services 3Health News:Novatus Unveils Milestone Software Release 2Health News:Survey Finds Support for the Affordable Care Act Among Physician Leaders 2Health News:Survey Finds Support for the Affordable Care Act Among Physician Leaders 3Health News:Sensato and Divurgent are pleased to announce the development of it’s new program “Designing Secure Healthcare Systems” 2Health News:Sensato and Divurgent are pleased to announce the development of it’s new program “Designing Secure Healthcare Systems” 3Health News:Sensato and Divurgent are pleased to announce the development of it’s new program “Designing Secure Healthcare Systems” 4
... disorders (TD) was first described about 40 years ago. ... (PA) and Thyroiditis on the basis of gastric and ... on this frequently overlooked association. , A research article ... World Journal of Gastroenterology investigates the overlooked association. A ...
... with the annual,HIMSS healthcare IT conference, RemoteScan Corporation,( ... new pricing of,its popular RemoteScan(R) software. RemoteScan makes ... software to scan directly into any,medical document management ... or Windows Terminal Services servers. In addition to ...
... week Citi-Mobile,launched a new mobile billboard campaign to ... generously donated their mobile,billboards to the National Autism ... family assistance, and cutting-edge,research., The mobile billboards ... the cities of Glendale and Burbank. Kevin Bartanian, ...
... heart disease, study finds , , WEDNESDAY, Feb. 27 (HealthDay News) ... and adolescents with normal blood sugar levels had elevated markers ... for both type 2 diabetes and cardiovascular disease. , Researchers ... 10 to 18. Of those, 17 were lean and 21 ...
... WASHINGTON, Feb. 27 Following is the daily,Black History ... WEDNESDAY, FEBRUARY 27: INCOME & HEALTH INSURANCE, ... Month. The progress,of any segment of the U.S. population ... financial health. Recent figures show that the annual median ...
... Oriental,Bioengineering, Inc. (NYSE: AOB ), a leading manufacturer ... that,it plans to release fourth quarter and full year ... 2008 before the market opens., The Company will ... ET to,discuss results. Listeners may access the call by ...
Cached Medicine News:Health News:Does artificial intelligence help clinicians to recognize atrophic gastritis with thyroid disease? 2Health News:RemoteScan - Scanner Connectivity Software for EMR (Electronic Medical Record) Systems 2Health News:Overweight Hispanic Kids Show Early Markers for Diabetes 2Health News:American Oriental Bioengineering to Report Fourth Quarter and Full Year 2007 Financial Results 2
(Date:8/3/2015)... 2015  Sage Analytics ( www.sageanalytics.com ), the developers ... measurement systems, announced its sponsorship of the California Cannabis ... limited number of tickets are available for groups or ... cause while enjoying an open bar, buffet dinner and ... Francisco Bay at sunset. With the legislative ...
(Date:8/3/2015)... 2015 Global physiotherapy ... USD 24.7 billion by 2022, according to a ... prevalence of neurological and musculoskeletal disorders are expected ... forecast period. The presence of efficient and effective ... the technologies coupled with implementation of favorable government ...
(Date:8/3/2015)... Biosensors International Group, Ltd. ("Biosensors" or ... B20), a developer, manufacturer and marketer of innovative ... first fiscal quarter ended 30 June 2015 ("Q1 ... Developments: , Biosensors continued to ... driven by lower operating expenses and operational improvement. ...
Breaking Medicine Technology:Sage Analytics Sponsors California Cannabis Industry Association Bay Area Cruise FUNdraiser 2Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 2Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 3Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 4Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 5Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 2Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 3Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 4Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 5Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 6