GSK Stands By Avandia: Seeks Label Change, Asks Docs To Give It Another Try
Executive Summary
Armed with new safety data, GlaxoSmithKline says it remains committed to Avandia, with hopes of a fresh label from the FDA and a change of heart from doctors who had ditched the troubled type 2 diabetes drug
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Participants in the ongoing safety debate over GlaxoSmithKline's Avandia (rosiglitazone) are refining their arguments ahead of the July 13-14 joint FDA advisory committee meeting on the troubled thiazolidinedione's future
Avandia Safety Rhetoric Ramps Up Ahead Of Advisory Committee Review
Participants in the ongoing safety debate over GlaxoSmithKline's Avandia (rosiglitazone) are refining their arguments ahead of the July 13-14 joint FDA advisory committee meeting on the troubled thiazolidinedione's future
Avandia Advisory Cmte. Is FDA's Primary Response To Congressional Pressure
Sponsors will get another look in July at how FDA interprets guidance for assessing the cardiovascular risk of diabetes drugs in clinical trials. The venue will be a meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees