AstraZeneca gains FDA approval for Bydureon Pen

The FDA approved AstraZeneca's Bydureon Pen (exenatide) as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes, the company reported Monday. The drugmaker said that the product is a pre-filled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process.

Bydureon was first authorised by the FDA in 2012, with AstraZeneca noting that the new presentation contains the same formulation and dose as the original single-dose tray, providing the same continuous release of exenatide. The drugmaker indicated that Bydureon Pen delivers exenatide via microsphere technology in a once-weekly dose requiring no titration. The product will be made available to patients in the US later this year.

AstraZeneca gained full rights to Bydureon, which is approved in 42 countries, earlier this year after the company bought the entirety of Bristol-Myers Squibb's interest in the drugmakers' diabetes alliance.

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