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12-24-2009, 01:19 PM | #1 | |||
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http://www.pharmalot.com/2009/12/fda...28Pharmalot%29
FDA Wants More Byetta Studies: Analyst 1 Comment By Ed Silverman // December 24th, 2009 // 8:10 am The (FDA)agency wants Amylin Pharmaceuticals to run more studies of its Type 2 diabetes drug, which was approved two months ago as a stand-alone treatment, due to safety concerns over pancreatitis... ... You may recall the twice-daily injectable drug was linked to six deaths last year (see here), which hurt sales. However, the Amylin statement didn’t mention additional studies... the (FDA)agency considers post-marketing reports of acute pancreatitis, acute renal failure and thyroid neoplasm to be new safety info. Amylin and Lilly, its Byetta marketing partner, issued a statement saying most of the studies are already under way and have not shown any increased risk of acute pancreatitis... Older discussion about byetta and PD: http://neurotalk.psychcentral.com/sh...ghlight=byetta http://neurotalk.psychcentral.com/sh...ghlight=byetta
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