On 16 September 2026, the FDA recorded a supplement to new drug application NDA021560 for Zortress (everolimus), held by Novartis. Zortress is the transplant formulation of everolimus, used with reduced-dose calcineurin inhibitors to prevent rejection after kidney and liver transplantation.
The FDA record does not state what the supplement changes. Supplements commonly concern labelling, manufacturing or packaging. There is no safety communication or new indication attached to this record.
Everolimus is itself a sensitive CYP3A4 and P-glycoprotein substrate with a narrow therapeutic range, so any label revision is worth checking for interaction or monitoring changes when the updated label is published.
- No change to everolimus prescribing follows from this record alone.
- Everolimus requires trough level monitoring; strong CYP3A4 inhibitors and inducers should be avoided.
- Check the updated label once published for any change to interaction or monitoring advice.
Why it matters
For a narrow-therapeutic-index transplant drug, even a label revision can change how levels are managed.
Don't overread it
A licence supplement is an administrative filing, not a new indication or safety finding.
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 clinical pharmacology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free