FDA approves Bydureon Pen formulation for Type 2 Diabetes - AstraZeneca

AstraZeneca has announced that the FDA has approved the Bydureon Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. Bydureon should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. Bydureon is not recommended as first-line therapy for patients who have inadequate glycaemic control on diet and exercise. Bydureon is not a substitute for insulin. The concurrent use of Bydureon with insulin has not been studied and is not recommended. Bydureon is the first and only once-weekly medicine for adults with type 2 diabetes.

The Bydureon Pen 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. The Bydureon Pen contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide.