Takeda Responds to the FDA Advisory Committee Recommendation.
PR Newswire Europe, July, 2007
LONDON, July 31 /PRNewswire/ --
Following a joint meeting today of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Takeda Global Research & Development (TGRD) underscores its position that ACTOS(R) (pioglitazone HCl) offers a proven safety profile regarding the risk of cardiovascular disease.
"The breadth and depth of ACTOS data - encompassing more than 16,000 patients over the past 10 years-is consistent: Short- and long-term studies have shown no evidence that ACTOS is associated with an increased risk of heart attack or stroke," said Dr. Nico Bruyniks, Director Medical and Scientific Affairs at Takeda Pharmaceuticals Europe LTD....
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