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Avandia press kit

The information on this page is intended for business journalists and analysts/investors.

Avandia (rosiglitazole maleate) was the subject of an article in the 14 June 2007 edition of the New England Journal of Medicine (NEJM*) about cardiovascular risk. This page provides various press releases, background documents and letters about GlaxoSmithKline's response to the NEJM article.

 

Press releases

• 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
• 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 (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
• 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

 

Letters and testimony

• 30 January 2008 - GSK responds to letter from Senator Grassley (PDF 71Kb)
• 27 September 2007 - GSK response to Baltimore Sun article (PDF 15Kb)
• 21 September 2007 - GSK response to LA Times article (PDF 14Kb)
• 18 September 2007 - GSK response to article in Newsday (PDF 17Kb)
• 12 June 2007 - GSK CEO's response to editorial in USA Today (PDF 17Kb)
• 6 June 2007 - Statement of Moncef Slaoui, PhD, Chairman Research & Development, GlaxoSmithKline (PDF 382Kb)
• 30 May 2007 - GSK letter published by The Lancet

Background documents

• Avandia: updated US prescribing information - Nov 2007 (PDF 448Kb)
• Avandia: Consumer update from US FDA
• Avandia: FDA information for healthcare professionals (PDF 35Kb)
• Avandia: FDA statement on safety alert (PDF 20Kb)
• Avandia: The Lancet editorial (PDF 64Kb)

Fact sheets

• 30 July 2007 - Avandia fact sheet (PDF 29Kb)
• 30 July 2007 - Avandamet fact sheet (PDF 28Kb)
• 30 July 2007 - Avandaryl fact sheet (PDF 28Kb)
• 30 July 2007 - Type II diabetes fact sheet (PDF 19Kb)
• 30 July 2007 - Type II diabetes complications fact sheet (PDF 556Kb)

Additional information

• 30 July 2007 - Diabetes complications report (PDF 479Kb)
• 30 July 2007 - FDA consumer update
• 30 July 2007 - FDA healthcare professionals (PDF 35Kb)

Prescribing information

• 30 July 2007- Avandia US prescribing information (PDF 304Kb)
• 30 July 2007 - Avandamet US prescribing information (PDF 287Kb)
• 30 July 2007- Avandaryl US prescribing information (PDF 282Kb)

* N Engl J Med 356:2457, June 14, 2007

 

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