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Amylin's Bydureon NDA Data Held Back, FDA Says

By Peter Winter
BioWorld Insight Editor

Wednesday, June 27, 2012
When Amylin Pharmaceuticals Inc. received the "green light" from the FDA in January to market its glucagon-like peptide-1 (GLP-1) receptor agonist, Bydureon (exenatide), as an adjunct to diet and exercise for improving glycemic control in adults with Type II diabetes, little did anyone know the full reasons why it had taken the company three tries to get approval.

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