Navigation Links
GSK and Valeant Announce New U.S. FDA PDUFA Goal Date for Ezogabine
Date:8/30/2010

LONDON, RESEARCH TRIANGLE PARK, N.C., and ALISO VIEJO, Calif., Aug. 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine* to 30 November 2010.  The original goal date was 30 August 2010.

The FDA has not yet completed the review of the New Drug Application (NDA) for ezogabine due to the recent submission of a formal REMS (Risk Evaluation and Mitigation Strategy) for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial onset seizures. The REMS was requested by FDA in correspondence dated 16 August 2010 and submitted to the FDA on 26 August 2010.  

The NDA was submitted to the FDA on 30 October 2009.  The companies will continue to work closely with FDA as the Agency completes its review.

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 – Valeant Pharmaceuticals International (NYSE: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology.  More information about Valeant can be found at www.valeant.com.

GlaxoSmithKline cautionary statement re
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Valeant to Acquire Polish Products
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
4. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
5. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
6. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
7. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
8. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
9. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
10. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
11. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)...  HyGreen, Inc., a leader in hand hygiene monitoring, today ... a subsidiary of Ascendis Health Limited, in ... hundreds of millions of patients around the world are ... from patient to patient via the unwashed hands of ...
(Date:1/23/2015)... , Jan. 23, 2015   Leatt Corporation  (OTCQB: ... protective equipment for all forms of sports, including extreme ... neck brace, announced today that the UISP Lega Motociclismo ... requires all riders to wear a neck brace during ...
(Date:1/23/2015)... , Jan. 23, 2015 Tianyin Pharmaceutical Inc. (NYSE ... specializes in the development and sale of patented biopharmaceutical ... active pharmaceutical ingredients (API) today announced the business and ... operation. 1. Following the September 2014 JCM ...
Breaking Medicine Technology:HyGreen Partners with RCA Medical in Johannesburg, South Africa 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 3TPI's JCM Updates on Import Registration for International Clients 2TPI's JCM Updates on Import Registration for International Clients 3TPI's JCM Updates on Import Registration for International Clients 4
... Levels With Doses an Order of Magnitude Lower than ... , , BETHESDA, Md., June 24 Spherix ... diabetes therapy, and a provider of technical and regulatory ... today announced positive preliminary results from a Phase 2 ...
... comply with recent FDA guidance for earlier testing-- ... Covance Inc. today announced ... Food and Drug Administration (FDA) guidance on Metabolites in ... human absorption, metabolism and excretion (AME) testing in support ...
Cached Medicine Technology:Spherix Announces Positive Phase 2 Study Results 2Spherix Announces Positive Phase 2 Study Results 3Spherix Announces Positive Phase 2 Study Results 4Spherix Announces Positive Phase 2 Study Results 5Spherix Announces Positive Phase 2 Study Results 6Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies 2Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies 3
(Date:1/22/2015)... Jolla, Calif. (PRWEB) January 22, 2015 ... Assemblymembers Susan Bonilla (D-Concord) and Kristin Olsen (R-Modesto) ... for their leadership in advancing biotechnology, biomedical science, ... Bonilla and Olsen each received the “2014 Life ...
(Date:1/22/2015)... City, Florida (PRWEB) January 22, 2015 IsoComforter, ... cold therapy machine with patented IsoTube design to treat specific ... has introduced the most progressive and easy to use patented ... treat post-operative and sports related orthopedic and muscle injuries. ...
(Date:1/22/2015)... Payday lending practices in four southern states ... distress to the states that permit them, according to ... on Race and Wealth. , While they generate hundreds ... at the same time substantially depress economic activity, according ...
(Date:1/22/2015)... 2015 As interest in the value of ... momentum worldwide, Rev. Eric J. Hall , president and ... (HCCN), will be the keynote speaker on January 27 at ... health system. , The conference, “Hope and Resilience: Innovative and ...
(Date:1/22/2015)... has released a new blog post presenting a list of vehicles ... , Some types of vehicles cannot be covered under an ... post to see if their vehicle qualifies for auto insurance coverage. ... the cars that cannot be covered by a plan. Clients have ...
Breaking Medicine News(10 mins):Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:Some Vehicles Cannot Be Covered By An Auto Insurance Policy! 2
... Board of Directors , , Expected ... N.J., March 18 eFoodSafety.com, Inc. (OTC Bulletin Board: ... portfolio of aesthetic, dermatology, environmental and nutraceutical products, today ... Inc. to Nuvilex, Inc. The Company is also announcing ...
... CHICAGO, March 18 International Components Corporation (ICC), ... portable rechargeable systems, today launched a new series ... The new 150-watt series, designed for both industrial ... converter efficiency of up to 94% and an ...
... Transplanted Into the Jaw to Generate Dense Bone Tissue ... Jason Morgan needs a dental implant to restore ... be difficult due to a lack of strong, healthy ... Southern California-based dentist and founder of Platinum Dental, will ...
... repercussion in the treatment of epilepsy has been ... Mintzer, M.D., assistant professor in the Department of ... Jefferson Medical College of Thomas Jefferson University. ... most commonly prescribed anti-seizure medications may lead to ...
... device,manufacturer Ziehm Imaging launched the new, compact Ziehm ... in Vienna. This agile and versatile,C-arm delivers excellent ... provides flexible image display options and exceptional flexibility ... designed to meet the needs,of pain management and ...
... of comprehensive medical record solutions for healthcare providers, ... Wednesday, March 25th at their headquarters in Paramus, ... will focus on the rollout of the new ... to promote the integration of electronic medical records ...
Cached Medicine News:Health News:eFoodSafety.com, Inc. Changes Name to Nuvilex, Inc., Reflecting New Strategic Direction of Company 2Health News:eFoodSafety.com, Inc. Changes Name to Nuvilex, Inc., Reflecting New Strategic Direction of Company 3Health News:eFoodSafety.com, Inc. Changes Name to Nuvilex, Inc., Reflecting New Strategic Direction of Company 4Health News:Convection Cooled 150-Watt Open Frame Power Supply Meets Medical and Industrial Safety Standards 2Health News:Southern California Dentist First on the West Coast to Perform Concentrated Stem Cell Transplant for Dental Implant Procedure 2Health News:Southern California Dentist First on the West Coast to Perform Concentrated Stem Cell Transplant for Dental Implant Procedure 3Health News:New research suggests common anti-seizure medications may increase risk of cardiovascular problems 2Health News:Ziehm Imaging Introduces Ziehm Solo C-arm, Featuring a Versatile set-up in the OR and Exceptional Image Quality 2Health News:Ziehm Imaging Introduces Ziehm Solo C-arm, Featuring a Versatile set-up in the OR and Exceptional Image Quality 3Health News:Microwize to Hold Free Stimulus Package Workshop for Medical Industry 2Health News:Microwize to Hold Free Stimulus Package Workshop for Medical Industry 3
... bed side and near patient testing is ... growth has posed unique problems for hospitals ... quality responsibility to decentralized areas focused on ... the problem is the reality of controlling ...
... The GenoSensor System includes genomic ... software, and reagents. By utilizing ... (CGH) technology for multi-target assessment, ... analyze multiple genomic targets in ...
... The CELL-DYN 3700 combines optical light ... Polarized Scatter Separation (MAPSS) to fully ... to improve performance and productivity in ... the revolutionary concept of complementary technologies ...
... Data Networking is hospital bedside glucose ... networking. In seconds, point of care ... from nursing stations throughout the hospital ... available to laboratory staff and the ...
Medicine Products: