Overview
Deferasirox is an iron chelator and the first oral medication FDA approved for chronic iron overload in patients receiving long term blood transfusions.
Indication
For the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
Associated Conditions
- Chronic Iron Overload
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/17 | Phase 2 | Not yet recruiting | |||
2024/06/21 | Not Applicable | Completed | |||
2022/05/26 | Phase 2 | Completed | |||
2020/06/09 | N/A | Completed | |||
2019/04/19 | Phase 2 | Terminated | Fondazione Italiana Sindromi Mielodisplastiche-ETS | ||
2018/09/06 | N/A | UNKNOWN | |||
2018/08/20 | Phase 2 | Completed | |||
2018/01/02 | Phase 2 | Completed | University Hospital, Grenoble | ||
2017/12/13 | Phase 4 | Completed | |||
2017/06/29 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actavis Pharma, Inc. | 45963-456 | ORAL | 500 mg in 1 1 | 8/31/2021 | |
| Sun Pharmaceutical Industries, Inc. | 57664-769 | ORAL | 180 mg in 1 1 | 12/12/2022 | |
| Actavis Pharma, Inc. | 0591-4730 | ORAL | 90 mg in 1 1 | 1/17/2024 | |
| Alembic Pharmaceuticals Limited | 46708-412 | ORAL | 360 mg in 1 1 | 1/30/2023 | |
| Sun Pharmaceutical Industries, Inc. | 62756-570 | ORAL | 500 mg in 1 1 | 12/26/2023 | |
| Dr. Reddy's Laboratories Inc | 43598-855 | ORAL | 125 mg in 1 1 | 12/30/2020 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1276 | ORAL | 180 mg in 1 1 | 7/24/2023 | |
| Amneal Pharmaceuticals NY LLC | 69238-1702 | ORAL | 90 mg in 1 1 | 12/29/2023 | |
| Aurobindo Pharma Limited | 59651-410 | ORAL | 90 mg in 1 1 | 11/15/2023 | |
| Dr. Reddy's Laboratories Inc | 43598-854 | ORAL | 500 mg in 1 1 | 12/30/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/26/2019 | ||
Authorised | 9/26/2019 | ||
Authorised | 8/28/2006 | ||
Authorised | 8/28/2006 | ||
Authorised | 1/9/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| JADENU FILM COATED TABLET 360MG | SIN15215P | TABLET, FILM COATED | 360.00mg | 4/18/2017 | |
| JADENU FILM COATED TABLET 90MG | SIN15213P | TABLET, FILM COATED | 90mg | 4/18/2017 | |
| FERASIRO FILM COATED TABLET 360MG | SIN17087P | TABLET, FILM COATED | 360.00mg | 9/19/2024 | |
| FERASIRO FILM COATED TABLET 90MG | SIN17088P | TABLET, FILM COATED | 90.00mg | 9/19/2024 | |
| DESROXIA FILM-COATED TABLETS 360MG | SIN17173P | TABLET, FILM COATED | 360.00 mg | 2/6/2025 | |
| DESROXIA FILM-COATED TABLETS 90MG | SIN17174P | TABLET, FILM COATED | 90.00 mg | 2/6/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| JADENU TABLETS 90MG | N/A | N/A | N/A | 10/31/2016 | |
| JADENU TABLETS 90MG | N/A | N/A | N/A | 11/27/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| JADENU deferasirox 180 mg film-coated tablet blister pack | 286761 | Medicine | A | 3/15/2018 | |
| DESIROX deferasirox 360 mg tablet blister pack | 338145 | Medicine | A | 4/21/2021 | |
| EFERAS deferasirox 180 mg film coated tablet blister pack | 331685 | Medicine | A | 3/12/2021 | |
| PHARMACOR DEFERASIROX deferasirox 125 mg dispersible tablet bottle pack | 302061 | Medicine | A | 9/9/2020 | |
| PHARMACOR DEFERASIROX deferasirox 500 mg dispersible tablet blister pack | 302067 | Medicine | A | 9/9/2020 | |
| JADENU deferasirox 360 mg film-coated tablet blister pack | 293497 | Medicine | A | 3/15/2018 | |
| JADENU deferasirox 90 mg film-coated tablet blister pack | 286751 | Medicine | A | 3/15/2018 | |
| Deferasirox Lupin deferasirox 360 mg film coated tablet blister pack | 341234 | Medicine | A | 8/6/2021 | |
| Deferasirox TLB deferasirox 90 mg film coated tablet blister pack | 341232 | Medicine | A | 8/6/2021 | |
| Deferasirox Sandoz deferasirox 360 mg film-coated tablet blister pack | 362235 | Medicine | A | 5/28/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DEFERASIROX (TYPE J) | 02527340 | Tablet - Oral | 90 MG | N/A | |
| DEFERASIROX (TYPE J) | 02527359 | Tablet - Oral | 180 MG | N/A | |
| SANDOZ DEFERASIROX | 02464462 | Tablet For Suspension - Oral | 250 MG | 7/4/2017 | |
| SANDOZ DEFERASIROX (TYPE J) | 02489902 | Tablet - Oral | 180 MG | 4/19/2021 | |
| TEVA-DEFERASIROX (TYPE J) | teva canada limited | 02531313 | Tablet - Oral | 360 MG | N/A |
| JADENU | novartis pharmaceuticals canada inc | 02452219 | Tablet - Oral | 90 MG | 3/24/2016 |
| APO-DEFERASIROX (TYPE J) | 02485281 | Tablet - Oral | 360 MG | 5/29/2019 | |
| JAMP DEFERASIROX (TYPE J) | 02549859 | Tablet - Oral | 360 MG | N/A | |
| TARO-DEFERASIROX (TYPE J) | 02507315 | Tablet - Oral | 90 MG | 3/4/2021 | |
| APO-DEFERASIROX | 02461552 | Tablet For Suspension - Oral | 250 MG | 6/29/2017 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| DEFERASIROX ABDI 180 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Abdi Farma Gmbh | 87278 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Not Commercialized |
| DEFERASIROX STADA 90 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 84911 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| DEFERASIROX VIVANTA 360 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Vivanta Generics S.R.O. | 84529 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| DEFERASIROX PHARMATHEN 90 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 86901 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Not Commercialized | |
| DEFERASIROX AUROVITAS 90 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 86261 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| DEFERASIROX RATIOPHARM 360 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 85548 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| DEFERASIROX TARBIS 360 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 88088 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Not Commercialized |
| FERUPANTIL 90 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Bexal Farmaceutica S.A. | 86034 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
| DEFERASIROX ZENTIVA 360 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 84885 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| DEFERASIROX TEVA 360 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 85516 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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