FDA — authorised 31 July 2023
- Application: ANDA206078
- Marketing authorisation holder: SUN PHARM
- Local brand name: SAXAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 DPP-4 inhibitors in United States
FDA authorised DPP-4 inhibitors on 31 July 2023
Marketing authorisations
FDA — authorised 31 July 2023
- Application: ANDA205941
- Marketing authorisation holder: AMNEAL
- Local brand name: SAXAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2023
- Application: ANDA205972
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SAXAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2023
- Application: ANDA205980
- Marketing authorisation holder: MYLAN
- Local brand name: SAXAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2023
- Application: ANDA205994
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: SAXAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA205942
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: SAXAGLIPTIN;METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA205959
- Marketing authorisation holder: PAR PHARM
- Local brand name: SAXAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
DPP-4 inhibitors 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 DPP-4 inhibitors approved in United States?
Yes. FDA authorised it on 31 July 2023; FDA authorised it on 31 July 2023; FDA authorised it on 31 July 2023.
Who is the marketing authorisation holder for DPP-4 inhibitors in United States?
SUN PHARM holds the US marketing authorisation.