The FDA approved a supplement to abbreviated new drug application ANDA 211482 for dapagliflozin, held by Ajanta Pharma, on 2 September 2026. An abbreviated application is the route for a generic version of an approved medicine; a supplement amends an existing authorisation rather than creating a new product, and the public record does not say what was changed.
So this is not a label change, a new indication or a safety action, and should not be described as one. What it is worth noting is the direction of travel. Dapagliflozin's kidney indication rests on trial evidence in chronic kidney disease with and without diabetes, and the main obstacle to using it at the scale that evidence supports has always been cost rather than doubt. Actions on generic applications are the machinery by which that cost falls.
The clinical reminders attached to the class are worth restating because they are what stop clinicians starting it. Expect an initial dip in eGFR of a few mL/min in the first weeks, which is haemodynamic and reverses on stopping; it is not a reason to discontinue. Counsel on genital mycotic infection and on sick-day rules, holding the drug during acute illness with poor oral intake because of euglycaemic ketoacidosis. Continue it well below the glycaemic thresholds it was first approved at, since kidney benefit persists where glucose lowering does not.
This action governs the United States market only, and Indian availability and labelling follow CDSCO rather than the FDA.
- Do not stop an SGLT2 inhibitor for the expected early eGFR dip; recheck rather than discontinue
- Give explicit sick-day rules: hold during acute illness with vomiting, fasting or poor oral intake
- Warn about genital mycotic infection at the outset, which is common, treatable and a frequent reason patients stop on their own
- Continue for kidney protection at eGFR levels where the glucose-lowering effect has largely gone
- Note this is a US action; Indian availability and labelling follow CDSCO
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for nephrology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free