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Avandia resource centre: press releases

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This page provides various press releases about Avandia (rosiglitazone maleate) and is intended for business journalists and analysts/investors.

2011

• 7 Feb 2011: GSK revises US Avandia label to include new restrictions on use

2010

• 23 Sep 2010: Stock Exchange Announcement: GSK regulatory update on Avandia following EMA and FDA reviews
• 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)
• 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)
• 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)
• 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
• 20 Feb 2010 - GSK rejects conclusions reported in The New York Times story on Avandia

2009

• 5 June 2009 - Large, long-term study, RECORD, shows Avandia has no increased overall cardiovascular risk compared to other commonly used diabetes medicines

2008

• 8 April 2008 - GlaxoSmithKline confirms receipt of FDA letter on regulatory reporting
• 6 February 2008 - GlaxoSmithKline responds to findings in ACCORD study
• 24 January 2008 - GlaxoSmithKline to revise Avandia® (rosiglitazone maleate) label in Europe following assessment by CHMP

2007

• 11 December 2007 - GlaxoSmithKline responds to JAMA article on the ICES thiazolidinediones and cardiovascular outcomes in older patients with diabetes
• 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)
• 3 December 2007 - GSK response to Nature Medicine article on rosiglitazone and bone in mice
• 14 November 2007 - GlaxoSmithKline revises US labeling for Avandia®
• 11 September 2007 - GlaxoSmithKline responds to JAMA articles
• 14 August 2007 - GlaxoSmithKline updates prescribing information for Avandia® in the US
• 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
• 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
• 16 July 2007 - GSK responds to reviews of oral diabetes medications (PDF 98Kb)
• 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
• 21 May 2007 - GSK response to US Senate Committee on Finance