Ferriprox

Treats transfusional iron overload. NDA 21825, held by Chiesi. Deferiprone.

As of Nov 14, 2026, NDA 21825 (Ferriprox), held by Chiesi, was first approved by FDA on Oct 14, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 14, 2011
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitation s 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Apr 30, 2021	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 25, 2019	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 14, 2011	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


Ferriprox500MG · tablet;oral	Deferiprone	DiscontinuedReference drug
Ferriprox1GM · tablet;oral	Deferiprone	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Mar 26, 2025	Supplement 12Labeling · Standard review	Approved	Letter Label Medication Guide
Nov 30, 2021	Supplement 10Labeling · Standard review	Approved	Label Letter
Apr 30, 2021	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 20, 2020	Supplement 7Labeling · Standard review	Approved	Letter Label
Jul 25, 2019	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 24, 2015	Supplement 3Labeling · Standard review	Approved	Label Letter
Nov 15, 2012	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 20, 2012	Supplement 1Labeling · Standard review	Approved	Letter Label
Oct 14, 2011	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 21825
Drugs@FDA: Overview at FDA
Company: Chiesi

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