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FDA delivers second complete response letter to Intarcia for ITCA-650 implant—a small, osmotic pump to treat type 2 diabetes.
The FDA has delivered a second Complete Response Letter to Intarcia for its ITCA-650 implant—a small, osmotic pump designed to be delivered under the skin and deliver a continuous, six-month dose of the GLP-1 agonist exenatide, also sold as Byetta and Bydureon. Typically a twice-daily or once-weekly injection, Intarcia’s formulation aims to stabilize the drug to keep it viable at human body temperature for extended periods of time.
Condition: Diabetes Type 2
Type: drug