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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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