Hyperphosphatemia
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FDA approval · 2017-08-11FDA Approved: LANTHANUM CARBONATE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic lantHanum carbonate under an original ANDA to treat hyperphosphatemia in adults with end-stage r…
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FDA label_change · 2017-08-03FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) to update the product labeling.
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FDA approval · 2017-07-17FDA Approved: SEVELAMER CARBONATE — Original Application (Aurobindo Pharma Limited)
FDA approved the original ANDA for Sevelamer carbonate by Aurobindo Pharma Limited.
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CLINICAL_TRIALS trial_result · 2017-06-28Clinical Trial Update: Hyperphosphatemia in Children With Chronic Kidney Disease [Phase 3]
Phase 3 clinical trial update examining hyperphosphatemia in children with chronic kidney disease; the current status is unknown.
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CLINICAL_TRIALS trial_result · 2017-06-21Clinical Trial Update: The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan [NA]
A terminated clinical trial evaluated whether sevelamer carbonate (Renvela) reduces atherosclerotic plaque inflammation in dialysis patients…
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FDA approval · 2017-06-13FDA Approved: SEVELAMER CARBONATE — Original Application (Aurobindo Pharma Limited)
FDA approves Sevelamer carbonate as a generic via an Original Application from Aurobindo Pharma Limited.
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CLINICAL_TRIALS trial_result · 2017-05-23Clinical Trial Update: The Efficacy of Niacin on Hyperphosphatemia in Patients Undergoing Haemodialysis [Phase 4]
Phase 4 clinical trial assessing the efficacy of niacin for hyperphosphatemia in patients undergoing haemodialysis. The current status of th…
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CLINICAL_TRIALS safety_alert · 2017-01-27Clinical Trial Update: Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
Post-marketing safety surveillance update assessing adverse events of Kiklin capsules in chronic kidney disease patients on hemodialysis wit…
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FDA approval · 2016-11-25FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for Sevelamer carbonate (Renvela) from Sanofi-Aventis U.S. LLC, updating the product labeling. The c…
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FDA approval · 2016-11-25FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for sevelamer carbonate (Renvela) submitted by Sanofi-Aventis U.S. LLC.
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FDA approval · 2016-11-09FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ferric Citrate submitted by Mylan Pharmaceuticals Inc., adding regulatory authorization for the …
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CLINICAL_TRIALS research · 2016-08-30Clinical Trial Update: Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia [Phase 4]
This document reports a Phase 4 clinical trial evaluating nicotinic acid for managing hyperphosphatemia in patients undergoing hemodialysis;…
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CLINICAL_TRIALS trial_result · 2016-07-25Clinical Trial Update: An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease [Phase 2]
This document summarizes a Phase 2 efficacy and safety study of sevelamer carbonate in hyperphosphatemic pediatric participants with chronic…
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CLINICAL_TRIALS trial_result · 2016-07-13Clinical Trial Update: A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis [Phase 3]
This report covers a long-term safety extension of ferric citrate in adults with end-stage renal disease on dialysis, part of a Phase 3 prog…
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CLINICAL_TRIALS trial_result · 2016-04-29Clinical Trial Update: Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients [NA]
A completed clinical trial evaluated whether dietary education and training on phosphate binder use improve phosphate control in hemodialysi…
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CLINICAL_TRIALS trial_result · 2016-03-14Clinical Trial Update: Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients [Phase 3]
This clinical trial update reports the Phase 3 open study of lanthanum carbonate (BAY77-1931) in continuous ambulatory peritoneal dialysis p…
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FDA approval · 2016-03-09FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for Sevelamer Hydrochloride submitted by Sanofi-Aventis U.S. LLC. This action constitutes a supp…
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FDA approval · 2016-03-09FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for Sevelamer carbonate from Sanofi-Aventis U.S. LLC.
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FDA approval · 2016-03-09FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for sevelamer carbonate, resulting in updated labeling for the product.
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FDA approval · 2016-02-24FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2016-02-24FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Fosrenol (lanthanum carbonate) submitted by Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS research · 2016-02-08Clinical Trial Update: A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis [Phase 1, Phase 2]
A dose-escalation Phase 1/2 clinical trial of VS-505 in patients with end-stage renal disease undergoing hemodialysis to address hyperphosph…
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CLINICAL_TRIALS trial_result · 2015-10-30Clinical Trial Update: Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects [Phase 1]
Phase 1 study assessed whether Colestilan affects the pharmacokinetics of a single dose of candesartan cilexetil in healthy subjects. The tr…
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FDA approval · 2015-10-26FDA Approved: CALCIUM ACETATE — Original Application (Westminster Pharmaceuticals, LLC)
The FDA approved the Original Application for calcium acetate from Westminster Pharmaceuticals, LLC, adding a generic calcium acetate produc…
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FDA label_change · 2015-08-27FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ferric Citrate from Mylan Pharmaceuticals, representing a label change to the product.