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US FDA accepts Bydureon app, sets PDUFA

This article was originally published in Scrip

Executive Summary

The US FDA said it would make a decision by 28 January 2012 on whether it would permit Amylin and its partner Lilly to market their once-weekly diabetes drug Bydureon (exenatide extended-release for injectable suspension) in the US, after accepting the firm's application and categorizing it as a Class 2 resubmission.



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