Deferasirox

Treats chronic iron overload due to blood transfusions. ANDA 216229, held by Annora Pharma. Deferasirox.

As of Nov 15, 2026, ANDA 216229 (Deferasirox), held by Annora Pharma, was first approved by FDA on Sep 22, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 22, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferasirox oral granules 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 3 submissions below

Date	Submission	Status	Documents
Sep 22, 2022	Original application	Approved	None posted

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Mar 19, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Mar 16, 2023	Supplement 1Manufacturing	Approved	None posted
Sep 22, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 216229
Drugs@FDA: Overview at FDA
Company: Annora Pharma

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