Deferasirox
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | JADENU SPRINKLE | — | 2018-05-11 – 2020-07-23 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | EXJADE | — | 2013-01-23 – 2019-07-24 | fda.gov ↗ |
| Approved | EU (EMA) | Exjade | — | 2006-08-28 | europa.eu ↗ |
| Approved | US (FDA) | EXJADE | — | 2005-11-02 | fda.gov ↗ |
Trials 83 · started per year
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2020-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 15th June, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Deferasirox Tablets, 180 mg. |
| 2020-05-07 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval from USFDA for Deferasirox Tablets for Oral Suspension zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Deferasirox Tablets for Oral Suspension (US RLD: Exjade TM Tablets for Oral Suspension) in the strengths of 125 mg, 250 mg and 500 mg. |
| 2020-02-17 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 15 generic drugs with 31 strengths. |
| 2019-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory 22nd November, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received approval from US Food & Drug Administration (USFDA) for its following Abbreviated New Drug Applications (ANDAs): |
| 2018-11-20 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Deferasirox Tablets zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Deferasirox Tablets, 90 mg, 180 mg, and 360 mg (US RLD – Exjade Tablets). |
| 2018-07-07 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Deferasirox Tablets for Oral Suspension zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Deferasirox Tablets for Oral Suspension (Exjade Tablets) in the strengths of 125 mg, 250 mg and 500 mg. |
| 2016-11-16 | Novartis Pharmaceuticals | Results Novartis data at ASH and SABCS showcase latest innovations in development for patients with blood disorders and breast cancer novartis.com ↗
Improved Patient-Reported Outcomes with a Film-Coated Versus Dispersible Tablet Formulation of Deferasirox: Results from the Randomized, Phase II ECLIPSE Study |
| 2015-03-30 | Novartis Pharmaceuticals | Regulatory Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload novartis.com ↗
Novartis announced today that the US Food and Drug Administration (FDA) has approved Jadenu TM (deferasirox) tablets, a new oral formulation of Exjade ® (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. |
All press releases naming this drug 10 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 102 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Deferasirox | “Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100” NCT06784336 ↗84“This will comprise of standard chelation drugs (Deferasirox or Deferoxamine or Combination of Deferoxamine and Deferiprone).” NCT02065492 ↗ “Patients will also continue the iron chelation therapy (Deferasirox, Deferiprone or Deferoxamine) in case of iron overload.” NCT07292259 ↗ “oral iron chelator Deferasirox -Exjade” NCT00452660 ↗ |
| Known as | Deferasirox dispersible tablet | “Deferasirox dispersible tablet (DFX-DT)” NCT02125877 ↗ |
| Known as | Deferasirox film-coated tablet | “Deferasirox film-coated tablet (DFX-FCT)” NCT02125877 ↗ |
| Known as | Deferasirox, (Exjade) | “Deferasirox, (Exjade)” NCT00901199 ↗ |
| Known as | DFX | “Comparison of safety, efficacy, compliance, treatment satisfaction, and quality of life (QoL) of two regimens: deferiprone (DFP) and deferoxamine (DFO) versus DFP and...” PMID 25600572 ↗ Mar 20155“Deferasirox (DFX) monotherapy is effective for reducing myocardial and liver iron concentrations (LIC), although some patients may require intensive chelation for a limited duration.” PMID 25934475 ↗ May 2015 “combined therapy with deferasirox (DFX, 20-30 mg/kg daily) and deferoxamine (DFO, 35-50mg/kg on 3-7 days/week)” PMID 23151373 ↗ Nov 2012 “Deferasirox DFX, DT” NCT01868477 ↗ “Deferasirox (DFX)” NCT06468423 ↗ “DFX(Deferasirox)” NCT02198508 ↗ |
| Known as | DFX-DT | “Deferasirox dispersible tablet (DFX-DT)” NCT02125877 ↗ |
| Known as | DFX-FCT | “Deferasirox film-coated tablet (DFX-FCT)” NCT02125877 ↗ |
| Known as | Exjade() | “Background Following a clinical evaluation of deferasirox (Exjade) it was concluded that, in addition to baseline body iron burden, ongoing transfusional iron intake should be...” PMID 19951979 ↗ Nov 20098“The THALASSA (assessment of Exjade(®) in non-transfusion-dependent THALASSemiA patients) study assessed the efficacy and safety of deferasirox in iron-overloaded NTDT patients” PMID 25212456 ↗ Sep 2014 “Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100” NCT06784336 ↗ “Patient-reported outcomes of once-daily oral deferasirox (Exjade) in iron-overloaded patients with beta-thalassemia” PMID 20424435 ↗ Apr 2010 “Exjade® (deferasirox, ICL670)” NCT02233504 ↗ |
| Known as | ICL670 | “The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called...” NCT00600938 ↗16“Open Label, Multicenter Study to Evaluate Safety/Tolerability and Efficacy of Deferasirox (ICL670) in Myelodysplastic Syndrome Patients With Chronic Transfusional Hemosiderosis.” NCT00469560 ↗ “Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload” NCT00901199 ↗ “An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload” NCT00171210 ↗ “Drug: Deferasirox will be orally administered at a dose of 20 mg/kg once daily at evening for 5 days. Other Name: ICL670” NCT01511848 ↗ “An Open Label Trial Evaluating Cardiac T2* in Beta-thalassemia Patients on Deferasirox (ICL670) Treatment for 18 Months” NCT00447694 ↗ “Deferasirox (Exjade, ICL670) is an oral chelator with high iron-binding potency and selectivity.” NCT00171301 ↗ “Exjade® (deferasirox, ICL670)” NCT02233504 ↗ “Deferasirox (ICL670)” NCT00395629 ↗ “Deferasirox (ICL670)” NCT00110617 ↗ “Deferasirox (ICL670)” NCT00631163 ↗ |
| Known as | Jadenu | “Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100” NCT06784336 ↗2“JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.” NCT07157722 ↗ |
| Known as | osveral | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01369719 ↗ |
| Route | Oral | “The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is as effective and as safe as deferoxamine in preventing accumulation of iron in the...” NCT00061750 ↗ |