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FDA sets 6-month review for antidiabetic Bydureon

This article was originally published in Scrip

Executive Summary

The US FDA has set a PDUFA date of 22 October for the resubmission of Lilly/Amylin/Alkermes's once-weekly GLP-1 receptor agonist Bydureon (extended release exenatide). This represents a longer review period than several analysts had been expecting. Credit Suisse's Catherine Arnold for instance had previously said that the likelihood of a class1, 2-month, review was high.


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