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AstraZeneca: FDA Issues Complete Response Letter On SNDA For Farxiga - Quick Facts

AstraZeneca plc (AZN.L,AZN) received a complete response letter from the US FDA with respect to the supplemental New Drug Application for Farxiga (dapagliflozin) filed by the company as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes.

Farxiga (dapagliflozin) is an oral, once-daily selective inhibitor of SGLT2 indicated as both monotherapy and as part of combination therapy to improve glycaemic control as an adjunct to diet and exercise in adults with type-1 diabetes.

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