FDA — authorised 19 December 2017
- Marketing authorisation holder: MERCK SHARP DOHME
- Status: approved
🇺🇸 Steglatro in United States
FDA authorised Steglatro on 19 December 2017
Marketing authorisations
FDA — authorised 19 December 2017
- Application: NDA209803
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: STEGLATRO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 2017
- Application: NDA209805
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: STEGLUJAN
- Indication: TABLET — ORAL
- Status: approved
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 21 January 2025
- Application: ANDA216842
- Marketing authorisation holder: HIKMA
- Local brand name: ERTUGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
Steglatro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Steglatro approved in United States?
Yes. FDA authorised it on 19 December 2017; FDA authorised it on 19 December 2017; FDA authorised it on 19 December 2017.
Who is the marketing authorisation holder for Steglatro in United States?
MERCK SHARP DOHME holds the US marketing authorisation.