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US Capitol Capsule: For FDA, Avandia CV story ongoing

This article was originally published in Scrip

Executive Summary

Even though GlaxoSmithKline's once-upon-a-time blockbuster Type II diabetes medicine Avandia (rosiglitazone) and its related products, Avandamet and Avandaryl, are only available to about 3,300 US patients through a tightly controlled restricted access program – with retail pharmacy sales ceasing in November 2011 – the FDA is looking to rehash the products’ cardiovascular (CV) outcomes data.



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