Navigation Links
Regulatory Update - GSK and Valeant Respond to FDA on ezogabine
Date:4/18/2011

LONDON, RESEARCH TRIANGLE PARK, N.C. and MISSISSAUGA, Ontario, April 18, 2011 /PRNewswire/ -- GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) submitted the response on 15 April 2011 to the U.S. Food and Drug Administration (FDA) Complete Response letter received on 30 November 2010 for the New Drug Application (NDA) for ezogabine*.

Ezogabine is an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures.

For announcements regarding the regulatory status, including filing and approval information, of ezogabine outside the US (where it is called retigabine*), please visit www.gsk.com and www.valeant.com.

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

About Valeant – 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 5502Janet Morgan

(020) 8047 5502David Daley

(020) 8047 5502US Media enquiries:

Nancy Pekarek

(919) 483 2839Mary Anne Rhyne

(919) 483 2839Kevin Colgan

(919) 483 2839Sarah Alspach

(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 5419Jeff McLaughlin

(215) 751 7002Valeant Enquiries:Laurie W. Little

(949) 461 6002GlaxoSmithKline cautionary statement regarding forward-looking statementsUnder 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 2010.

Valeant Pharmaceuticals Forward-Looking StatementThis press release may contain forward-looking statements, including, but not limited to, statements regarding the initial review and assessment of the complete response letter, the ability to adequately address the issues raised in the complete response letter and the timing of any response to FDA. 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.  Registered in England & Wales:No. 3888792Registered Office:980 Great West Road

Brentford, Middlesex

TW8 9GS(Logo:  http://photos.prnewswire.com/prnh/20101025/LA87217LOGO)


'/>"/>

SOURCE Valeant Pharmaceuticals International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. IDEV Announces Full Canadian Regulatory Approval for SUPERA VERITAS®
2. Delcath Receives Notice of European Regulatory Approval for Hepatic CHEMOSAT™ Delivery System
3. MonoSol Rx Secures 505(b)(2) Regulatory Pathway for Montelukast Sodium Oral Soluble Film
4. PNP Therapeutics Meets Important Financial and Regulatory Objectives in Development of New Cancer Therapies
5. Novo Nordisk Submits First Recombinant Treatment for Factor XIII Deficiency for U.S. Regulatory Approval
6. Prima BioMed Receives Regulatory Scientific Advice on CVac Phase III Trial
7. Anthera Pharmaceuticals Names Lawrence Rosania as Vice President of Global Regulatory Affairs and Compliance
8. Crucell Shareholders Adopt Offer Governance Resolutions and Johnson & Johnson Makes Announcement on U.S. Regulatory Matters
9. VIVUS Provides Regulatory Update on QNEXA NDA
10. Regulatory Update - GSK and Valeant Receive Positive Opinion in Europe From the CHMP for Trobalt (Retigabine)
11. Jennerex Names Ursula Fritsch, PharmD, as Vice President, Regulatory Affairs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Issue 52" report to their offering. ... treatment creates a favourable commercial environment for MedImmune to enter. ... base that will serve to drive considerable growth for effective ... serve to cap sales considerably, but development is still in ...
(Date:6/23/2016)... LONDON , June 23, 2016 ... environments  Oticon , industry leaders in ... the launch of Oticon Opn ™, the world,s ... world of possibilities for IoT devices.      ... Opn, Oticon introduces a number of ,world firsts,: ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. ... magazine’s Code Talker Award, an essay contest in which patients and their families pay ... be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference ...
Breaking Medicine News(10 mins):