Related Information

• FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
  5/18/2011
• Decision on continued marketing of rosiglitazone (Avandia, Avandamet, Avandaryl) (PDF - 167KB)
  Janet Woodcock, MD , Director, Center for Drug Evaluation and Research
• Recommendations for Regulatory Action for Rosiglitazone and Rosiglitazonecontaining Products (NDA 21-071, supplement 035, incoming submission dated August 25, 2009) - 9/12/2010 (PDF - 148KB)
  Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology
• Comments on the study by Wertz et al. published in Circulation 2010 (PDF - 46KB)
  David J. Graham, MD, MPH, Associate Director for Science and Medicine, Office of Surveillance and Epidemiology
• Analysis of Medicare thiazolidinedione study data by date of birth - 9/1/2010 (PDF - 47KB)
  David J. Graham, MD, MPH, Associate Director for Science and Medicine, Office of Surveillance and Epidemiology
• Recommendations for regulatory actions – rosiglitazone - 9/2/2010 (PDF - 152KB)
  John K. Jenkins, M.D., Director Office of New Drugs
• Recommendations on marketing status of Avandia® (rosiglitazonemaleate) and the required post-marketing trial, Thiazolidinedione Intervention and Vitamin D Evaluation (TIDE) following the July 13 and 14, 2010 public advisory committee meeting - 8/19/2010 (PDF - 185KB)
  Mary H. Parks, M.D., Director, Division of Metabolism and Endocrinology Products
• Pioglitazone Secondary Statistical Review (PDF - 37KB)
  Mark Levenson, Ph.D., Acting Deputy Division Director, Division of Biometrics 7
• Pioglitazone Statistical Review - 9/10/2010 (PDF - 441KB)
  Qian H. Li, Sc.D.
• Avandia (rosiglitazone) AC Memo - 8/23/2010 (PDF - 100KB)
  Curtis J. Rosebraugh, M.D., M.P.H., Director, Office of Drug Evaluation II
• Avandia (rosiglitazone) Memo - 8/8/2010 (PDF - 178KB)
  Robert Temple, M.D., Deputy Center Director for Clinical Science
• Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information
• Q&A: Avandia (rosiglitazone)
• FDA significantly restricts access to the diabetes drug Avandia
  FDA News Release - 9/23/2010
• Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration
  New England Journal of Medicine - 9/23/2010
• FDA Drug Safety Podcast: FDA significantly restricts access to the diabetes drug Avandia
• HHS FDA: Briefing on Avandia
  FDA Avandia announcement audio - 9/23/2010
• Avandia (NDA 021071) - Safety Labeling Change, REMS, and PMR Notification (PDF - 75KB)

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