FDA — authorised 8 January 2014
- Marketing authorisation holder: ASTRAZENECA AB
- Status: approved
🇺🇸 Farxiga in United States
FDA authorised Farxiga on 8 January 2014
Marketing authorisations
FDA — authorised 6 April 2026
- Application: ANDA211506
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211156
- Marketing authorisation holder: INVENTIA
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211523
- Marketing authorisation holder: AIZANT
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211531
- Marketing authorisation holder: LUPIN LTD
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211533
- Marketing authorisation holder: MSN
- Status: approved
Farxiga in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Farxiga approved in United States?
Yes. FDA authorised it on 8 January 2014; FDA authorised it on 6 April 2026; FDA authorised it on 6 April 2026.
Who is the marketing authorisation holder for Farxiga in United States?
ASTRAZENECA AB holds the US marketing authorisation.