Transfusional Iron Overload
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CLINICAL_TRIALS trial_result · 2024-12-27Clinical Trial Update: Safety of SP-420 in the Treatment of Transfusional Iron Overload [Phase 1]
Phase 1 trial evaluating safety of SP-420 for transfusional iron overload has been terminated.
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FDA approval · 2023-10-16FDA Approved: DEFERASIROX — Original Application (NorthStar Rx LLC)
FDA approves NorthStar Rx LLC's original generic application for deferasirox, a once-daily oral iron chelator for reducing chronic iron over…
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FDA approval · 2023-04-28FDA Approved: DEFERASIROX ORAL GRANULES — Supplemental Application (EPIC PHARMA, LLC)
The FDA approved a supplemental application to authorize Deferasirox Oral Granules (DEFERASIROX) from Epic Pharma, LLC, for the treatment of…
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FDA approval · 2022-09-23FDA Approved: DEFERASIROX — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva's Deferasirox as an original generic application, enabling broader access to this iron chelation therapy for patients with…
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FDA approval · 2022-02-23FDA Approved: DEFERASIROX — Original Application (Cipla USA Inc.)
FDA approves a generic version of deferasirox (Cipla) under an original ANDA application.
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CLINICAL_TRIALS trial_result · 2020-08-03Clinical Trial Update: Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis [Phase 4]
Phase 4 safety study of crushed deferasirox film-coated tablets in pediatric patients with transfusional iron overload completed; results po…
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FDA approval · 2020-06-16FDA Approved: DEFERASIROX — Original Application (Dr. Reddy's Laboratories Inc)
FDA approves Dr. Reddy's Laboratories' deferasirox generic under ANDA210945 for the treatment of chronic iron overload due to blood transfus…
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CLINICAL_TRIALS trial_result · 2017-03-01Clinical Trial Update: A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional Hemosiderosis [Phase 3]
This clinical trial update announces the completion of a Phase 3 study evaluating deferasirox for long-term treatment in patients with beta-…
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CLINICAL_TRIALS research · 2017-02-23Clinical Trial Update: A Protocol to Allow Treatment With ICL670 for Patients With or at Risk of Life-threatening Complications of Transfusional Iron Overload Who Are Unable to Tolerate Other Iron Chelators Because of Documented Severe Toxicity [Phase 2]
A Phase 2 protocol update from Novartis to allow treatment with ICL670 for patients with life-threatening transfusional iron overload who ca…
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CLINICAL_TRIALS trial_result · 2017-02-23Clinical Trial Update: Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload [Phase 4]
Novartis-sponsored Phase 4 trial assessing heart and liver iron load by MRI in patients with transfusion-related iron overload; the study st…
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CLINICAL_TRIALS trial_result · 2016-09-21Clinical Trial Update: High-Tc Susceptometer to Monitor Transfusional Iron Overload
Clinical trial update reporting that the study evaluating a High-Tc Susceptometer to monitor transfusional iron overload has completed, in p…
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CLINICAL_TRIALS trial_result · 2015-06-03Clinical Trial Update: Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload [Phase 2]
Phase 2 safety and pharmacodynamic study of an oral iron chelator given for 6 months in patients with transfusional iron overload and beta-t…
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CLINICAL_TRIALS trial_result · 2015-05-27Clinical Trial Update: Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload [Phase 2]
Phase 2 trial assessing safety, efficacy, and pharmacokinetics of an oral iron chelator administered for one year in pediatric patients with…
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CLINICAL_TRIALS trial_result · 2015-03-19Clinical Trial Update: Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload [Phase 2]
An extension study evaluating the iron chelator deferasirox in patients with transfusional iron overload has completed in Phase 2.
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CLINICAL_TRIALS trial_result · 2014-08-27Clinical Trial Update: Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload [Phase 2]
Phase 2 trial comparing deferasirox to deferoxamine for treating cardiac iron overload in patients with transfusional iron overload. The stu…
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CLINICAL_TRIALS trial_result · 2013-11-15Clinical Trial Update: Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study [Phase 4]
A Phase 4 GI tolerability study of deferasirox in patients with myelodysplastic syndrome and transfusional iron overload conducted by Novart…
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CLINICAL_TRIALS trial_result · 2013-04-24Clinical Trial Update: Active Drug Surveillance Program of Ferriprox Use
The Active Drug Surveillance Program for Ferriprox (deferiprone) use in transfusional iron overload has completed.
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FDA label_change · 2012-07-18FDA Approved: DEFEROXAMINE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Deferoxamine (Deferoxamine Mesylate) from Fresenius Kabi USA, LLC, likely involving changes to l…
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FDA approval · 2012-06-20FDA Approved: DEFEROXAMINE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Deferoxamine Mesylate (Deferoxamine) from Fresenius Kabi USA, LLC.
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CLINICAL_TRIALS trial_result · 2012-02-10Clinical Trial Update: Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload [Phase 1]
Phase 1 safety and pharmacokinetic study evaluating escalating doses of an investigational iron chelator in patients with Transfusional Iron…
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CLINICAL_TRIALS trial_result · 2011-08-15Clinical Trial Update: A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload. [Phase 2]
A 4-year extension study of deferasirox for iron chelation in pediatric β-thalassemia major patients with transfusional iron overload comple…
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CLINICAL_TRIALS trial_result · 2011-05-02Clinical Trial Update: An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload [Phase 3]
Extension study results for deferasirox (ICL670) used to treat transfusional iron overload in patients with β-thalassemia; results were post…
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FDA approval · 2007-04-20FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for EXJADE (deferasirox) submitted by Novartis Pharmaceuticals Corporation, resulting in an approved…