Deferasirox

Treats chronic iron overload due to blood transfusions. ANDA 213374, held by Alkem Labs Ltd. Deferasirox.

As of Nov 15, 2026, ANDA 213374 (Deferasirox), held by Alkem Labs Ltd, was first approved by FDA on Jul 14, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 14, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferasirox 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 2 submissions below

Date	Submission	Status	Documents
Jul 14, 2020	Original application	Approved	Letter

Products

3 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Mar 27, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Jul 14, 2020	Original application	Approved	Letter

Identifiers

Application: ANDA 213374
Drugs@FDA: Overview at FDA
Company: Alkem 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