Zortress

Prevents organ rejection. NDA 21560, held by Novartis. Everolimus.

As of Nov 14, 2026, NDA 21560 (Zortress), held by Novartis, was first approved by FDA on Apr 20, 2010, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 20, 2010
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a: Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5 ) Limitations of Use: Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk Recipients of transplanted organs other than kidney or liver ( 1.3, 5.7 ) Pediatric patients (less than 18 years) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below


Oct 12, 2016	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 15, 2013	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 20, 2010	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

4 strengths and forms


Zortress0.25MG · tablet;oral	Everolimus	RxReference drug
Zortress0.5MG · tablet;oral	Everolimus	RxReference drug
Zortress0.75MG · tablet;oral	Everolimus	RxReference drug
Zortress1MG · tablet;oral	Everolimus	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Sep 16, 2026	Supplement 34Labeling · Standard review	Approved	Label Letter
Feb 28, 2024	Supplement 32Labeling · Standard review	Approved	Label Medication Guide
Sep 14, 2023	Supplement 33Labeling · Standard review	Approved	Letter Label
Apr 13, 2023	Supplement 31Manufacturing	Approved	Letter
Aug 10, 2018	Supplement 22Manufacturing · Standard review	Approved	Letter Label
Jan 12, 2018	Supplement 21Labeling · Standard review	Approved	Label
Jan 12, 2018	Supplement 20Labeling · Standard review	Approved	Letter Label
Oct 12, 2016	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 1, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 5, 2015	Supplement 18Labeling	Approved	Label Letter
Jun 24, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 27, 2015	Supplement 11Labeling · Standard review	Approved	Label Letter
Dec 5, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 14, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 26, 2013	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 15, 2013	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 2, 2012	Supplement 8Labeling · Standard review	Approved	Letter Label
May 2, 2012	Supplement 9REMS	Approved	Letter
Apr 26, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Nov 21, 2011	Supplement 4REMS	Approved	Letter
Apr 20, 2010	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 21560
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters