Navigation Links
GlaxoSmithKline Statement in Response to FDA Advisory Committees' Vote on Safety of Avandia® (rosiglitazone)
Date:7/14/2010

PHILADELPHIA, July 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions (20) to withdrawal from the U.S. market (12).  

"Following today's recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease," Dr. Ellen Strahlman, GSK's Chief Medical Officer, said.  "Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine."

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will now be considered by the FDA in making its final decision.  Pending the FDA's decision, Avandia remains available to physicians and appropriate patients as an option to help control blood sugar in patients with type 2 diabetes.

Strahlman continued:  "GSK is dedicated to sharing data about its medicines transparently and in a timely manner.  We remain fully committed to maintaining best practice disclosure of clinical data to serve the interests of regulators, physicians and patients."

Avandia is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients.  The company has consistently shared data with the
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. ImaginAb, Inc. and GlaxoSmithKline Establish Collaboration
2. Johnson Controls Secures Global Facilities Management Win With GlaxoSmithKline
3. North Carolina GlaxoSmithKline Foundation Working With Nonprofits to Promote Health, Science and Education Through Ribbon of Hope Grants
4. Cellzome Announces Second Major Strategic Drug Discovery Alliance with GlaxoSmithKline in Inflammatory Disease
5. GlaxoSmithKline Responds to US Senate Committee on Finance Report on Avandia
6. GlaxoSmithKline President of North America Pharmaceuticals, Deirdre Connelly, Named 2010 Woman of the Year by the Healthcare Businesswomens Association
7. GlaxoSmithKline 14th Annual IMPACT Awards Seek Greater Philadelphia and Camden Healthcare Nonprofits
8. GlaxoSmithKline and NanoBio Announce OTC Licensing Agreement for Cold Sore Treatment
9. Federal Judge Rejects GlaxoSmithKlines Claims of Privilege
10. FDA approves GlaxoSmithKlines VOTRIENT(TM) for advanced renal cell cancer
11. FDA Approves Cervarix, GlaxoSmithKlines Cervical Cancer Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... , July 30, 2014   Unique ... Groups Inc.: OTC Pink: UPZS), a Delaware Corporation, ... distribution agreement with Larasan Pharmaceutical Corporation ("Larasan"), a nature-based ... According to the agreement, US-based Larasan will work ... 6" frozen pizza through Larasan,s vast distribution network ...
(Date:7/30/2014)... 2014 Silicon Valley Bank, the bank of ... that examines the merger, acquisition and IPO activity ... to the annual report based on 2013 data, venture ... SVB started tracking the data in 2005. ... solid healthcare M&A activity over the last few years, ...
(Date:7/30/2014)...  Lightlake Therapeutics Inc. ("Lightlake") (OTCQB: LLTP), a ... expertise in opioid antagonists, announced today that it ... international research and development foundation. The ... initiatives, including those addressing health issues. Lightlake has ... of naloxone that could widely expand its availability ...
Breaking Medicine Technology:Unique Pizza and Subs Announces Asian Distribution Agreement with Larasan Pharmaceutical Corporation 2Unique Pizza and Subs Announces Asian Distribution Agreement with Larasan Pharmaceutical Corporation 3Report: Biopharma and Medical Device Companies Beat Historic Investment Returns 2Report: Biopharma and Medical Device Companies Beat Historic Investment Returns 3Lightlake Therapeutics Inc. Receives Funding Commitment From A Prominent International Research And Development Foundation 2Lightlake Therapeutics Inc. Receives Funding Commitment From A Prominent International Research And Development Foundation 3
... Fourth - Quarter 2010 Highlights ... Gross profit increased by 5.8% over Q4 FY09 to $8.8 ... $3.1 million with EPS of $0.13 Full Fiscal ... $115.0 million Gross Profit increased 23.7% YOY to $34.6 million ...
... Otonomy, Inc . announced today that David A. Weber, ... of the Board of Directors. Jay Lichter, Ph.D., managing director of ... continue to actively support the company as a member of the ... Dr. Weber to the Otonomy team, as his extensive experience in ...
Cached Medicine Technology:Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 2Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 3Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 4Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 5Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 6Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 7Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 8Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 9Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 10Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 11Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 12Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 13Winner Medical Reports Fourth Quarter and Fiscal 2010 Results 14Otonomy Appoints David A. Weber, Ph.D., Chief Executive Officer 2Otonomy Appoints David A. Weber, Ph.D., Chief Executive Officer 3
(Date:7/30/2014)... Serial entrepreneur, Paul Mata, spent the early ... like most people, in 2008 he suffered extreme financial hardship ... way, Paul carefully studied the difference between people who have ... Based on the knowledge he acquired, he was able to ... and health, but also grow his clients' personal and financial ...
(Date:7/30/2014)... , Resistance to artemisinin, the main drug to ... among the Plasmodium falciparum ( P. ... is likely caused by a genetic mutation in ... combination therapyas opposed to a standard three-day coursehas ... according to findings published today in the ...
(Date:7/30/2014)... Volunteers from the Church of Scientology ... this summer with massive distribution of Truth About ... these volunteers on Strøget, the famous Copenhagen walking street. ... shopping and its ambiance, some quarter of a million ... day. , These activities are part of a ...
(Date:7/30/2014)... July 30, 2014 Visitors to our ... over $8,500 to ensure its protection. Bob Kiesendahl, one ... check to the Delaware Highlands Conservancy for donations collected ... small $2-per-stay donations add up fast, as visitors welcome ... Upper Delaware River Region. , The Kiesendahl family has ...
(Date:7/30/2014)... A new network of 25 regional stroke centers and ... StrokeNet) is working to change the way stroke ... of the last two decades, stroke remains a major ... disability for 795,000 Americans. The numbers are expected to ... , To accelerate the pace of progress, NIH StrokeNet ...
Breaking Medicine News(10 mins):Health News:Paul Mata Kicks off 3-day Wealth Bootcamp on September 11th 2Health News:Paul Mata Kicks off 3-day Wealth Bootcamp on September 11th 3Health News:Resistance to key malaria drug spreading at alarming rate in Southeast Asia 2Health News:Pocono Mountain Resort Guests Contribute Over $8500 to Protect Land in 6 Short Months 2Health News:Kessler funded as satellite site for NIH Stroke Trials Network 2
... www.deo.ucsf.edu , has been launched by the University of California, ... successful American Diabetes Association (ADA) accredited teaching program curriculum created by ... the past 30 years. , ... SAN FRANCISCO ...
... Successful And Effective Campaign Could Help Prevent,Another Blood Crisis, ... Just Six Coaches, Orlando Has 35!!!, NEW YORK, ... a dangerous blood emergency, New York City Councilman Eric ... and,Investigation, and representatives of New York Blood Center called ...
... Findley Davies announced today,the hiring of Tod ... Charlotte,Office effective August 1, 2008. He will be ... Benefits Practice in North Carolina and,surrounding areas. Tod ... as a Health and Welfare consultant for a ...
... new report on severe sporting injuries among high school ... a larger proportion of all such injuries than previously ... of North Carolina at Chapel Hill-based National Center for ... for 65.1 percent of all catastrophic sports injuries among ...
... Aug. 11 STAAR Surgical,Company (Nasdaq: STAA ... invasive ophthalmic products, announced today that it will,present ... Financial Equity,Conference which will be held Monday, August ... Lake Las Vegas Resort, Nevada. Barry G. Caldwell,President ...
... Consumables Revenue Up 15% Year over Year ... Gross Profit Margin of 77%, HAYWARD, ... non-invasive tissue tightening in the aesthetic,industry, today reported its financial results for ... of 2008 totaled $17.9 million, an,increase of 2% from $17.5 million for ...
Cached Medicine News:Health News: 80 Million Americans Can Benefit from New Diabetes Resource : Free Educational Website Created by UCSF Diabetes Teaching Center Goes Live 2Health News:Gioia & New York Blood Center Call for City Aid in Expansion of Mobile Blood Donor Coach Program 2Health News:Gioia & New York Blood Center Call for City Aid in Expansion of Mobile Blood Donor Coach Program 3Health News:UNC study: Two-thirds of severe sports injuries to female students due to cheerleading 2Health News:STAAR Surgical to Present at the Noble Financial Equity Conference 2Health News:Thermage Announces Second Quarter 2008 Financial Results 2Health News:Thermage Announces Second Quarter 2008 Financial Results 3Health News:Thermage Announces Second Quarter 2008 Financial Results 4Health News:Thermage Announces Second Quarter 2008 Financial Results 5Health News:Thermage Announces Second Quarter 2008 Financial Results 6Health News:Thermage Announces Second Quarter 2008 Financial Results 7Health News:Thermage Announces Second Quarter 2008 Financial Results 8Health News:Thermage Announces Second Quarter 2008 Financial Results 9
Molteno3 Glaucoma Drainage Device incorporates the latest advances from Professor Moltenos glaucoma research. It has been extensively tested since early 2004 and gives even better control of intraocu...
... 2.0 is a reagent and probe system ... The high throughput plate based system is ... provides a unique approach for RNA detection ... using branched DNA (bDNA) technology. Branched DNA ...
Cormet Hip Resurfacing is a conservative treatment for the young, active, high demand patient group which conserves femoral bone, provides anatomical bone loading, eliminates polyethylene and is desi...
QC 123 is an assayed quality control material for blood gas instrumentation. It is available in three (3) levels for monitoring analyzer performance at varying points within the clinical range....
Medicine Products: