Deferiprone

Treats transfusional iron overload. ANDA 213239, held by Hikma. Deferiprone.

As of Nov 14, 2026, ANDA 213239 (Deferiprone), held by Hikma, was first approved by FDA on Mar 29, 2021, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 29, 2021
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Limitations of Use:

Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. Pediatric use information is approved for Chiesi USA, Inc.’s FERRIPROX (deferiprone) tablets. However, due to Chiesi USA, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 29, 2021	Original application	Approved	None posted

Products

2 strengths and forms


Deferiprone500MG · tablet;oral	Deferiprone	Rx
Deferiprone1GM · tablet;oral	Deferiprone	Rx

All 5 submissions, including labeling and manufacturing supplements


Aug 15, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Nov 22, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Jan 14, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Oct 21, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Mar 29, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 213239
Drugs@FDA: Overview at FDA
Company: Hikma

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