FDA Says Amylin Hid Diabetes Drug Safety Data

Law360, New York (June 27, 2012, 5:23 PM ET) -- Amylin Pharmaceuticals Inc. withheld heart safety data from regulators while seeking approval for its extended-release diabetes drug Bydureon, which the U.S. Food and Drug Administration eventually approved in January, according to an agency report recently made public.

The FDA said in a January 27 review of the approval process that while it granted Amylin's request to rely on the safety and effectiveness findings of the regular version of the drug, Byetta, the company wasn't transparent in its disclosure of areas that needed to be considered in...
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