Myfortic

Prevents organ rejection. NDA 50791, held by Novartis. Mycophenolate Sodium.

As of Nov 14, 2026, NDA 50791 (Myfortic), held by Novartis, was first approved by FDA on Feb 27, 2004, with 28 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2004
Review: Standard
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Use in combination with cyclosporine and corticosteroids. Limitations of Use: Myfortic delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Myfortic (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Feb 27, 2004	Original applicationNew active ingredient · Standard review	Approved	Other Review Letter

Products

2 strengths and forms


MyforticEQ 180MG BASE · tablet, delayed release;oral	Mycophenolate Sodium	RxReference drug
MyforticEQ 360MG BASE · tablet, delayed release;oral	Mycophenolate Sodium	RxReference drug

All 29 submissions, including labeling and manufacturing supplements


Jul 29, 2026	Supplement 43REMS	Approved	Label Medication Guide Letter
Jul 29, 2026	Supplement 42Labeling · Standard review	Approved	Label Letter
Jun 27, 2025	Supplement 40Labeling · Standard review	Approved	Letter Label
Aug 13, 2024	Supplement 38REMS	Approved	Letter
Mar 15, 2022	Supplement 35Labeling · Standard review	Approved	Letter Label
Aug 11, 2021	Supplement 36REMS	Approved	Letter
Apr 21, 2021	Supplement 34REMS	Approved	Letter
Jan 15, 2021	Supplement 33REMS	Approved	Letter
Nov 3, 2020	Supplement 32Manufacturing	Approved	Label Letter
Apr 28, 2020	Supplement 30Labeling · Standard review	Approved	Letter Label
Dec 23, 2015	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 13, 2015	Supplement 22REMS	Approved	Letter
Oct 27, 2015	Supplement 24Labeling · Standard review	Approved	Letter Label
Aug 4, 2015	Supplement 21Manufacturing · Standard review	Approved	Letter
Sep 27, 2013	Supplement 19REMS	Approved	Letter Label
Sep 27, 2013	Supplement 18Labeling · Standard review	Approved	Letter Label
May 1, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
May 1, 2013	Supplement 12Labeling · Standard review	Approved	Label Letter
Feb 8, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 25, 2012	Supplement 5Labeling · Standard review	Approved	Letter
Jun 22, 2012	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 27, 2010	Supplement 11Labeling	Approved	Letter Label
Oct 8, 2009	Supplement 8Labeling	Approved	Letter Label
Jul 10, 2009	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 27, 2009	Supplement 6Labeling · Standard review	Approved	Letter
Dec 15, 2008	Supplement 4Labeling · Standard review	Approved	Label Letter
May 9, 2008	Supplement 2Labeling · Standard review	Approved	Label Letter
Nov 2, 2007	Supplement 1Labeling · Standard review	Approved	Letter Label
Feb 27, 2004	Original applicationNew active ingredient · Standard review	Approved	Other Review Letter

Identifiers

Application: NDA 50791
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