FDA — authorised 28 August 2015
- Application: NDA202270
- Marketing authorisation holder: MSD SUB MERCK
- Indication: Labeling
- Status: approved
🇺🇸 sitagliptin and metformin in United States
FDA authorised sitagliptin and metformin on 28 August 2015 · 34 US adverse-event reports
Marketing authorisations
FDA — authorised 4 December 2020
- Application: NDA022044
- Marketing authorisation holder: MSD SUB MERCK
- Indication: Efficacy
- Status: approved
FDA — authorised 3 November 2023
- Application: NDA216743
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 18 July 2024
- Application: NDA216778
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved sitagliptin and metformin for marketing in the United States. This approval was granted to ZYDUS LIFESCIENCES under the new formulation or new manufacturer indication (Type 5). The approval date was 18 July 2024, and the application number is NDA216778.
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: 34
Most-reported reactions
- Completed Suicide — 4 reports (11.76%)
- Dizziness — 4 reports (11.76%)
- Drug Ineffective — 4 reports (11.76%)
- Pain In Extremity — 4 reports (11.76%)
- Abnormal Dreams — 3 reports (8.82%)
- Diarrhoea — 3 reports (8.82%)
- Malaise — 3 reports (8.82%)
- Nausea — 3 reports (8.82%)
- Pain — 3 reports (8.82%)
- Somnolence — 3 reports (8.82%)
sitagliptin and metformin 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 sitagliptin and metformin approved in United States?
Yes. FDA authorised it on 28 August 2015; FDA authorised it on 4 December 2020; FDA authorised it on 3 November 2023.
Who is the marketing authorisation holder for sitagliptin and metformin in United States?
MSD SUB MERCK holds the US marketing authorisation.