FDA — authorised 18 January 2012
- Application: ANDA201991
- Marketing authorisation holder: INVENTIA
- Status: approved
🇺🇸 METFORMIN in United States
FDA authorised METFORMIN on 18 January 2012 · 213,877 US adverse-event reports
Marketing authorisations
FDA — authorised 28 August 2015
- Application: NDA202270
- Marketing authorisation holder: MSD SUB MERCK
- Indication: Labeling
- Status: approved
FDA — authorised 5 April 2017
- Application: NDA021591
- Marketing authorisation holder: RANBAXY
- Indication: Labeling
- Status: approved
FDA — authorised 14 January 2021
- Application: ANDA213344
- Marketing authorisation holder: GRANULES
- Status: supplemented
FDA — authorised 11 August 2021
- Application: ANDA213359
- Marketing authorisation holder: UNICHEM
- Status: approved
FDA — authorised 17 September 2021
- Application: NDA209806
- Marketing authorisation holder: MSD SUB MERCK
- Indication: Efficacy
- Status: approved
FDA — authorised 22 February 2022
- Application: ANDA214629
- Marketing authorisation holder: SCIEGEN PHARMS
- Status: approved
FDA — authorised 14 April 2025
- Application: ANDA219151
- Marketing authorisation holder: BIONPHARMA
- Status: approved
FDA — authorised 20 June 2025
- Application: ANDA079009
- Marketing authorisation holder: HERITAGE
- Indication: Labeling
- Status: approved
The FDA approved METFORMIN for use in the United States on 20 June 2025. The marketing authorisation holder is HERITAGE. The application number for this approval is ANDA079009. METFORMIN is approved for use as per its labelling.
FDA — authorised 3 November 2025
- Application: ANDA208459
- Marketing authorisation holder: MSN
- 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: 213,877
Most-reported reactions
- Nausea — 29,156 reports (13.63%)
- Diarrhoea — 26,885 reports (12.57%)
- Blood Glucose Increased — 26,848 reports (12.55%)
- Drug Ineffective — 21,794 reports (10.19%)
- Fatigue — 20,627 reports (9.64%)
- Lactic Acidosis — 19,124 reports (8.94%)
- Vomiting — 18,718 reports (8.75%)
- Acute Kidney Injury — 17,541 reports (8.2%)
- Weight Decreased — 16,956 reports (7.93%)
- Dyspnoea — 16,228 reports (7.59%)
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 METFORMIN approved in United States?
Yes. FDA authorised it on 18 January 2012; FDA authorised it on 28 August 2015; FDA authorised it on 5 April 2017.
Who is the marketing authorisation holder for METFORMIN in United States?
INVENTIA holds the US marketing authorisation.