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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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