Treats transfusional iron overload. NDA 208030, held by Chiesi. Deferiprone.
As of Nov 13, 2026, NDA 208030 (Ferriprox), held by Chiesi, was first approved by FDA on Sep 9, 2015, with 5 approved supplements and 0 published complete response letters.
FERRIPROX Oral Solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias.
| Apr 30, 2021 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Apr 20, 2018 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 9, 2015 | Original applicationNew dosage form · Standard review | Approved |
| Ferriprox100MG/ML · solution;oral | Deferiprone | RxReference drug |
| Ferriprox80MG/ML · solution;oral | Deferiprone | DiscontinuedReference drug |
| Mar 26, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Nov 30, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Apr 30, 2021 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 20, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Apr 20, 2018 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 9, 2015 | Original applicationNew dosage form · Standard review | Approved |
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
