FDA — authorised 19 December 2017
- Application: NDA209805
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: STEGLUJAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 SGLT2 inhibitor in United States
FDA authorised SGLT2 inhibitor on 19 December 2017 · 4 US adverse-event reports
Marketing authorisations
FDA — authorised 19 December 2017
- Application: NDA209806
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: SEGLUROMET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2023
- Application: ANDA216947
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ERTUGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2024
- Application: ANDA217071
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: ERTUGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 January 2025
- Application: ANDA216842
- Marketing authorisation holder: HIKMA
- Local brand name: ERTUGLIFLOZIN
- Indication: TABLET — 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: 22 April 2025 – 22 April 2026
- Total reports: 4
Most-reported reactions
- Diabetic Ketoacidosis — 2 reports (50%)
- Infection — 1 report (25%)
- Lactic Acidosis — 1 report (25%)
SGLT2 inhibitor 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 SGLT2 inhibitor approved in United States?
Yes. FDA authorised it on 19 December 2017; FDA authorised it on 19 December 2017; FDA authorised it on 13 July 2023.
Who is the marketing authorisation holder for SGLT2 inhibitor in United States?
MSD SUB MERCK holds the US marketing authorisation.