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Avandia Adds Black Box For Heart Attack Risk; Actos Launches Ads

Executive Summary

FDA has unveiled the much-anticipated labeling change for GlaxoSmithKline's type 2 diabetes therapy Avandia, but is deeming the information about rosiglitzone's cardiovascular risk "inconclusive" and is asking the sponsor to undertake a long-term outcomes study to address outstanding safety questions

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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

GSK Stands By Avandia: Seeks Label Change, Asks Docs To Give It Another Try

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

GSK Stands By Avandia: Seeks Label Change, Asks Docs To Give It Another Try

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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