Deferasirox

Treats chronic iron overload due to blood transfusions. ANDA 210945, held by Msn. Deferasirox.

As of Nov 15, 2026, ANDA 210945 (Deferasirox), held by Msn, was first approved by FDA on Jun 16, 2020, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 16, 2020
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferasirox tablets are 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 6 submissions below


Jun 16, 2020	Original application	Approved	Letter
Nov 20, 2019	Original application	Approved	Letter

Products

3 strengths and forms


Deferasirox90MG · tablet;oral	Deferasirox	Rx
Deferasirox360MG · tablet;oral	Deferasirox	Rx
Deferasirox180MG · tablet;oral	Deferasirox	Rx

All 6 submissions, including labeling and manufacturing supplements


Dec 17, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Mar 1, 2021	Supplement 2Manufacturing	Approved	None posted
Mar 1, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Mar 1, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Jun 16, 2020	Original application	Approved	Letter
Nov 20, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 210945
Drugs@FDA: Overview at FDA
Company: MSN Laboratories

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