Jadenu

Treats chronic iron overload due to blood transfusions. NDA 206910, held by Novartis Pharms Corp. Deferasirox.

As of Nov 13, 2026, NDA 206910 (Jadenu), held by Novartis Pharms Corp, was first approved by FDA on Mar 30, 2015, with 14 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2015
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JADENU is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Jul 23, 2020	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Jul 26, 2019	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
May 24, 2019	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 12, 2018	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 11, 2018	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 30, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Jadenu90MG · tablet;oral	Deferasirox	RxReference drug
Jadenu180MG · tablet;oral	Deferasirox	RxReference drug
Jadenu360MG · tablet;oral	Deferasirox	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Feb 11, 2022	Supplement 19Manufacturing	Approved	Label Letter
Jul 23, 2020	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Jul 26, 2019	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
May 24, 2019	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 12, 2018	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 12, 2018	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 3, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
May 11, 2018	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 16, 2018	Supplement 7Labeling · Standard review	Approved	Letter Label
Jan 26, 2018	Supplement 5Labeling · Standard review	Approved	Label Letter
Aug 12, 2016	Supplement 4Labeling · Standard review	Approved	Label Letter
Nov 6, 2015	Supplement 2Manufacturing · Priority review	Approved	None posted
Oct 22, 2015	Supplement 1Labeling · Standard review	Approved	Letter Label
Oct 22, 2015	Supplement 3Labeling · Standard review	Approved	Letter Label
Mar 30, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 206910
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