FDA's Drugs@FDA database lists a supplement to NDA 215341, Bayer's finerenone marketed as Kerendia, dated 16 September. The record does not state what the supplement covers.
Supplements may be labelling updates, manufacturing changes or new indications. Until the revised label is posted, nothing changes for finerenone prescribing in diabetic kidney disease. Any Indian label change would come separately through CDSCO.
- No change to finerenone prescribing follows from this listing.
- Continue potassium monitoring at start and after dose changes.
- Check the FDA label when the revised version is posted.
Why it matters
Finerenone is a core drug in diabetic kidney disease, so its label changes matter.
Don't overread it
A licence supplement is not a new indication or a safety finding.
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