The FDA's application record carries an action on NDA 206111, Synjardy (empagliflozin with metformin hydrochloride), sponsored by Boehringer Ingelheim. It is a supplement to an existing approval and the record does not say what it covers. Companion actions on the extended-release formulations of the same and related combinations appear on the same sweep.
Nothing in prescribing changes on an application action alone. The renal indications for empagliflozin, and the eGFR thresholds for metformin, are set by the current label, and that is where the answer to any specific question lies.
The combination itself is worth a standing thought in a nephrology clinic. Fixed-dose empagliflozin-metformin is convenient until kidney function falls, at which point the two components need different decisions - the SGLT2 inhibitor is generally continued well into advanced chronic kidney disease while metformin needs dose reduction and eventually withdrawal. A fixed-dose combination makes that impossible without switching products, and patients on one are the patients most likely to end up taking metformin at an eGFR where it should have been stopped.
- Check the current FDA or CDSCO label rather than inferring anything from an application action
- Review fixed-dose SGLT2 inhibitor-metformin combinations whenever eGFR falls
- Metformin needs dose reduction and eventual withdrawal; the SGLT2 inhibitor usually does not
- Switch to separate components rather than stopping both when kidney function declines
- Empagliflozin-metformin combinations are widely marketed in India - the same review applies here
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