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Avandia Committee Gives Split Vote To Drug, But FDA Clear Winner

 
• By Cathy Dombrowski

A re-adjudication of cardiovascular events in the RECORD trial reassured members of a June 5-6 advisory committee that the study findings are reliable, but did not erase uncertainties about CV risk associated with rosiglitazone.

A second review of the RECORD trial for GlaxoSmithKline PLC’s Avandia (rosiglitazone meleate) left an advisory committee reassured about the reliability of the study’s findings, if not the cardiovascular safety of the diabetes drug, and also provided FDA with some cover for its handling of the product.

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