FDA Commissioner Defends Reaction To Avandia

Law360, New York (June 5, 2007, 12:00 AM EDT) -- The U.S. Food and Drug Administration has asked GlaxoSmithKline PLC, Takeda Pharmaceutical Co. and Eli Lilly & Company to add black box warnings—the strongest safety warning available—to diabetes drugs Avandia and Actos.

Dr. Andrew von Eschenbach, the commissioner of the FDA, announced the move Wednesday during his opening statements at a hearing of the U.S. House of Representatives Committee on Oversight and Reform. The hearing was called to consider the FDA's safety assessment of Avandia, which is made by GlaxoSmithKline. (Takeda and Lilly produce and market...
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