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FDA extends approval of Dapagliflozin

May 9, 2023

Based on the positive results from the DELIVER Phase III trial, the FDA has extended approval of dapagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure (HF) visits in adults with HF.

FDA approval means patients with heart failure can benefit from dapagliflozin (Farxiga®) regardless of left ventricular ejection fraction status. More details of the extended approval can be found at:

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