After FDA Review, GSK Could Earn Reprieve On Avandia

Law360, New York (June 4, 2013, 1:40 PM EDT) -- The U.S. Food and Drug Administration on Monday potentially moved closer to loosening restrictions on GlaxoSmithKline PLC's former blockbuster diabetes drug Avandia, after agency researchers backed a study downplaying the purported cardiovascular-related death risk of the drug, but with a caveat.

According to an FDA briefing, Duke University Clinical Research Institute's “independent readjudication” of data from an earlier GSK Avandia trial — Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes, or RECORD — was thorough, and had confirmed the drugmaker's finding that Avandia...
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