FDA Panel Votes To Restrict GSK's Avandia

Law360, New York (July 14, 2010, 4:33 PM EDT) -- A divided U.S. Food and Drug Administration advisory committee voted Wednesday to keep GlaxoSmithKline PLC's troubled diabetes drug Avandia on the market, although nearly one-third of the panelists recommended that the pill be banned outright.

Following two days of presentations from drugmakers, clinicians and FDA staff members, a joint panel of the agency's Endocrinologic and Metabolic Drugs advisory committee and Drug Safety and Risk Management advisory committee determined that rosiglitazone — the active ingredient in Avandia — presents an elevated risk of heart complications in diabetes...
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