FDA — authorised 6 April 2026
- Application: ANDA211533
- Marketing authorisation holder: MSN
- Status: approved
🇺🇸 dapagliflozin and saxagliptin in United States
FDA authorised dapagliflozin and saxagliptin on 6 April 2026
Marketing authorisation
dapagliflozin and saxagliptin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is dapagliflozin and saxagliptin approved in United States?
Yes. FDA authorised it on 6 April 2026.
Who is the marketing authorisation holder for dapagliflozin and saxagliptin in United States?
MSN holds the US marketing authorisation.