Treats transfusional iron overload. ANDA 220132, held by Pharmazone. Deferiprone.
As of Nov 14, 2026, ANDA 220132 (Deferiprone), held by Pharmazone, was first approved by FDA on Dec 11, 2025, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2025 | Original application | Approved |
| Deferiprone500MG · tablet;oral | Deferiprone | Rx |
| Deferiprone1GM · tablet;oral | Deferiprone | Rx |
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
