🇺🇸 Dapagliflozin (Forxiga) in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Dapagliflozin (Forxiga) on 8 January 2014

Marketing authorisation

FDA — authorised 8 January 2014

Application: NDA202293
Marketing authorisation holder: ASTRAZENECA AB
Local brand name: FARXIGA
Indication: TABLET — ORAL
Status: approved

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Frequently asked questions

Is Dapagliflozin (Forxiga) approved in United States?

Yes. FDA authorised it on 8 January 2014.

Who is the marketing authorisation holder for Dapagliflozin (Forxiga) in United States?

ASTRAZENECA AB holds the US marketing authorisation.