FDA — authorised 31 July 2023
- Application: ANDA205972
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SAXAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 SAXAGLIPTIN in United States
FDA authorised SAXAGLIPTIN on 31 July 2023 · 1,109 US adverse-event reports
Marketing authorisations
FDA — authorised 31 July 2023
- Application: ANDA205981
- Marketing authorisation holder: MYLAN
- Status: approved
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: ANDA205994
- Marketing authorisation holder: GLENMARK PHARMS LTD
- 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 9 August 2023
- Application: ANDA207678
- Marketing authorisation holder: DR REDDYS LABS SA
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211533
- Marketing authorisation holder: MSN
- Status: approved
FDA
- Application: ANDA205959
- Marketing authorisation holder: PAR PHARM
- 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
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,109
Most-reported reactions
- Nausea — 185 reports (16.68%)
- Fatigue — 129 reports (11.63%)
- Diarrhoea — 118 reports (10.64%)
- Vomiting — 111 reports (10.01%)
- Dizziness — 110 reports (9.92%)
- Asthenia — 100 reports (9.02%)
- Off Label Use — 92 reports (8.3%)
- Acute Kidney Injury — 88 reports (7.94%)
- Blood Glucose Increased — 88 reports (7.94%)
- Drug Ineffective — 88 reports (7.94%)
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 SAXAGLIPTIN 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 SAXAGLIPTIN in United States?
AUROBINDO PHARMA holds the US marketing authorisation.