FDA Approved: FARXIGA — Original Application (AstraZeneca Pharmaceuticals LP)

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Summary

FDA's original approval decision for Farxiga (dapagliflozin) by AstraZeneca, marking the initial marketing authorization for this SGLT2 inhibitor in the U.S.

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Diseases / indications

• Type 2 Diabetes Mellitus

Drugs mentioned

• FARXIGA (dapagliflozin)

Snippet

ORIG AP for FARXIGA (DAPAGLIFLOZIN)