Amneal announced FDA approval of exenatide 5mcg/1.2mL and 10mcg/2.4mL prefilled pen injection on November 21, 2024. This generic references Byetta® (exenatide – AstraZeneca), a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The initial dose of exenatide is 5mcg administered subcutaneously within 60 minutes before the morning and evening meals and then increased to 10mcg twice daily after one month based on glycemic control. Cost and launch information are not known at this time.
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