Bydureon Review Documents Paint An Unflattering Portrait Of Amylin

Division of Metabolism and Endocrinology Products Director Mary Parks said the review of exenatide extended-release was delayed and complicated by the company’s withholding of important information about the QT effects of Byetta, an assertion the sponsor disputes. Amylin’s appeal of a second “complete response” letter failed to overturn the requirement for a new QT study pre-approval.