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Avandia RECORD Study Re-Analysis To Get FDA Committee Scrutiny

 
• By Brenda Sandburg

Two FDA panels will jointly review an independent “re-adjudication” of GlaxoSmithKline’s RECORD study of Avandia’s cardiovascular risk; 12 of 33 panel members voted to withdraw the drug when they considered the RECORD data in 2010.

Three years after FDA requested an independent re-adjudication of GlaxoSmithKline PLC’s Avandia (rosiglitazone) RECORD study, the data will be presented to two FDA advisory panels.

The Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly discuss the “re-adjudication” of the Rosiglitazone Evaluated for Cardiovascular Outcomes

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