Navigation Links
Regulatory Update - GSK and Valeant Receive Positive Opinion in Europe From the CHMP for Trobalt (Retigabine)
Date:1/21/2011

MISSISSAUGA, Ontario, Jan. 21, 2011 /PRNewswire/ -- GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Trobalt (retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy.

Retigabine received a preliminary approval from the Swiss Agency for Therapeutic Products, Swissmedic, in December 2010.

Retigabine, referred to as ezogabine in the US, is being jointly developed by GSK and Valeant.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) - is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.  More information about Valeant can be found at www.valeant.com.GlaxoSmithKline Enquiries:UK Media enquiries:

David Mawdsley

(020) 8047 5502Claire Brough

(020) 8047 5502Stephen Rea

(020) 8047 5502Alexandra Harrison

(020) 8047 5502US Media enquiries:

Nancy Pekarek

(919) 483 2839Mary Anne Rhyne

(919) 483 2839Kevin Colgan

(919) 483 2839Jennifer Armstrong

(919) 483 2839European Analyst/Investor enquiries:

Sally Ferguson

(020) 8047 5543Gary Davies

(020) 8047 5503Ziba Shamsi

(020) 8047 3289US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419Valeant Enquiries: Laurie W. Little

(949) 461 6002GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.Valeant Pharmaceuticals Forward-Looking Statement This press release may contain forward-looking statements, including statements regarding the development or approval of ezogabine. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the Securities and Exchange Commission ("SEC") and other risks and uncertainties detailed from time to time in the Company's filings with the SEC and the Canadian Securities Administrators ("CSA"), which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.

*Editor's note: Ezogabine is the non-proprietary name adopted by the United States Adopted Name Council for use in the U.S. and Canada. Retigabine is the non-proprietary name adopted by the International Nonproprietary Name for Pharmaceuticals Substances Program for use in the rest of the world.  

(Logo: http://photos.prnewswire.com/prnh/20101025/LA87217LOGO)


'/>"/>
SOURCE Valeant Pharmaceuticals International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. EpiCept Reports Regulatory Progress on Ceplene(TM)
2. Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens
3. Anesiva Defines Regulatory Pathway for Adlea with FDA
4. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
5. EpiCept Provides Update on Clinical and Regulatory Progress with Ceplene(TM) and EpiCept(TM) NP-1 Cream
6. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
7. Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
8. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
9. PulmoBioTech Announces Details of Its Regulatory Approval Experiments
10. Morria Biopharmaceuticals Plc Announces Regulatory Approval to Commence Phase II Clinical Study of MRX-4 in Allergic Rhinitis
11. XTENT Announces European Regulatory Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology:
(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):