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Avandia resource centre: information by category
The information on this page is intended for business journalists and analysts/investors.
This page provides various press releases about Avandia (rosiglitazone maleate) organised into categories.
Scientific data and debate
- 6 Sep 2010: BBC Panorama – 6 September 2010: “A Risk Worth Taking?” Programme. GlaxoSmithKline Right of Reply Statement
- 6 Sep 2010: GlaxoSmithKline pre-broadcast statement: BBC Panorama, 6 September 2010
- 6 Sep 2010: GlaxoSmithKline responds to British Medical Journal article regarding Avandia® (rosiglitazone)
- 28 June 2010: GlaxoSmithKline statement in response to JAMA publications on rosiglitazone (PDF 76KB)
- 23 March 2010: GSK responds to JAMA editorial and comment (PDF 200KB)
- 20 Feb 2010 - GSK rejects conclusions reported in The New York Times story on Avandia
- 6 February 2008 - GlaxoSmithKline responds to findings in ACCORD study
- 11 December 2007 - GlaxoSmithKline responds to JAMA article on the ICES thiazolidinediones and cardiovascular outcomes in older patients with diabetes
- 3 December 2007 - GSK response to Nature Medicine article on rosiglitazone and bone in mice
- 11 September 2007 - GlaxoSmithKline responds to JAMA articles
- 27 July 2007 - GlaxoSmithKline statement in diabetes care study thiazolidinediones and heart failure: a teleo-analysis
- 17 July 2007 - GSK responds to online review of rosiglitazone by The Cochrane Collaboration
- 24 June 2007 - Data shows Avandia patients incur lower medical costs and use fewer healthcare resources
- 6 June 2007 - Newly published data from large study support cardiovascular safety of Avandia (rosiglitazone maleate)
- 5 June 2007 - GSK response to New England Journal of Medicine editorials
- 5 June 2007 - Data from GSK's RECORD study published in NEJM
- 30 May 2007 - Data affirms Avandia cardiovascular safety profile
- 21 May 2007 - GSK response to NEJM article
Regulatory action
- 7 Feb 2011: GSK revises US Avandia label to include new restrictions on use
- 23 Sep 2010: Stock Exchange Announcement: GSK regulatory update on Avandia following EMA and FDA reviews
- 21 July 2010: GlaxoSmithKline statement in response to FDA announcement on TIDE trial
- 14 July 2010: GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia® (rosiglitazone)
- 13 Jul 2010: GlaxoSmithKline (GSK) responds to Senate Finance Committee letter of 12 July to FDA
- 9 Jul 2010: Data support Avandia (rosiglitazone maleate) cardiovascular safety profile
- 9 Jul 2010: GSK EU regulatory update on Avandia (rosiglitazone)
- 8 April 2008 - GlaxoSmithKline confirms receipt of FDA letter on regulatory reporting
- 24 January 2008 - GlaxoSmithKline to revise Avandia® (rosiglitazone maleate) label in Europe following assessment by CHMP
- 4 December 2007 - Statement from GlaxoSmithKline: publication of update regarding thiazolidinediones to treatment guidelines for the management of type 2 diabetes mellitus by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA)
- 14 November 2007 - GlaxoSmithKline revises US labeling for Avandia®
- 14 August 2007 - GlaxoSmithKline updates prescribing information for Avandia® in the US (PDF 49Kb)
- 30 July 2007 - FDA Advisory Panel votes 22 to 1 for Avandia® to remain available to patients in the US
- 30 July 2007 - GlaxoSmithKline presents Avandia data to FDA
- 16 July 2007 - GSK responds to reviews of oral diabetes medications (PDF 98Kb)
US Senate
- 21 July 2010: GlaxoSmithKline statement in response to FDA announcement on TIDE trial
- 14 July 2010: GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia® (rosiglitazone)
- 13 Jul 2010: GlaxoSmithKline (GSK) responds to Senate Finance Committee letter of 12 July to FDA
- 24 Feb 2010: GlaxoSmithKline LLC’s white paper response to Senate Finance Committee's “Staff Report on GlaxoSmithKline and The Diabetes Drug Avandia”
- 24 Feb 2010: GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia
- 20 Feb 2010 - GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia
- 21 May 2007 - GSK response to US Senate Committee on Finance
