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news.The US Food and Drug Administration (FDA) has assigned a new Prescription Drug User Fee Act (PDUFA) action date of 28 January 2012 Bydureon (exenatide extended-release for injectable suspension (Byetta)).
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The agency plans to complete the whole review process by the date for Bydureon, an experimental medication for type 2 diabetes.
Earlier, Amylin and Lilly partnered to develop Bydureon, which is based on proprietary technology for long-acting medications developed by Alkermes.
Amylin Research and Development senior vice president Christian Weyer said if approved, they believe Bydureon will be an important new option for type 2 diabetes patients, as the first once-weekly treatment available in the US.
"We will continue to work with the FDA through this stage of the review process," Weyer said.