Deferasirox

Treats chronic iron overload due to blood transfusions. ANDA 211824, held by Alembic. Deferasirox.

As of Nov 15, 2026, ANDA 211824 (Deferasirox), held by Alembic, was first approved by FDA on Jun 15, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 15, 2020
Review: Standard
Supplements approved: 2
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. Limitations of Use: The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Jun 15, 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 4 submissions, including labeling and manufacturing supplements


Apr 12, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Apr 12, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Jun 15, 2020	Original application	Approved	Letter
Nov 20, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 211824
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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