Bydureon pen gets FDA approval

WILMINGTON, Del. — AstraZeneca received approval from the Food and Drug Administration for its Bydureon pen (exenatide extended-release for injectable suspension) 2-mg, which is to be used as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.



The Bydureon pen is a pre-filled, single-use pen injector, which eliminates the need for the patient to transfer their medication between a vial and syringe during the process of self-injection. The pen contains the same formula and dose as the original Bydureon single-dose tray.



“We are pleased to receive approval for the Bydureon Pen, which can provide a powerful reduction in blood glucose levels along with the potential benefit of weight loss, through a once-weekly dose in a pre-filled device,” said Briggs Morrison, M.D., EVP of global medicines development and chief medical officer for AstraZeneca. “We are committed to addressing the needs of adults with Type 2 diabetes, including ongoing research to develop new treatments and methods of delivery.”



AstraZeneca said it plans to make the pen available for patients later this year. The single-dose tray will remain on the market for patients prescribed Bydureon.