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FDA advisory committees to revisit Avandia data in June

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The FDA has announced that the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will once again review results from data on rosiglitazone maleate this June.

The 2-day meeting is scheduled for June 5 and 6. The committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial for a new drug application for rosiglitazone (Avandia, GlaxoSmithKline).

The drug belongs to a class known as thiazolidinediones and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

For more information:

See FDA Docket No. FDA-2013-N-0001.