June 5-6, 2013 8:00 a.m. to 5:00 p.m.: Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
Where: FDA White Oak Campus
Building 31 – The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue Silver Spring, MD
This FDA AdComm meeting will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline.
Please click HERE for the current roster of the Endocrinologic and Metabolic Drugs Advisory Committee.
Click HERE to view the FDA materials associated with this meeting.
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