Hyperphosphatemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-04-30FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for Sevelamer carbonate submitted by Sanofi-Aventis U.S. LLC.
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FDA label_change · 2020-04-10FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Exelan Pharmaceuticals Inc.)
FDA approved a supplemental application for Sevelamer carbonate from Exelan Pharmaceuticals Inc., resulting in updated labeling.
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FDA approval · 2020-03-25FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Sevelamer Carbonate from Aurobindo Pharma Limited, enabling its continued/expanded generic use.
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FDA approval · 2020-02-28FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
The FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) submitted by Fresenius Medical Care Renal Therapies Grou…
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FDA approval · 2020-02-21FDA Approved: CALCIUM ACETATE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for calcium acetate capsules (667 mg) from Rising Pharma Holdings, Inc., a generic product.
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EMA withdrawal · 2020-02-04EMA Lapsed: Fexeric (ferric citrate coordination complex) — Akebia Europe Limited
EMA has lapsed the marketing authorization for Fexeric (ferric citrate coordination complex) in Europe, with hyperphosphatemia and renal dia…
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CLINICAL_TRIALS trial_result · 2020-01-13Clinical Trial Update: Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis [Phase 4]
Phase 4 trial assessing safety and efficacy of Nephoxil® in subjects with end-stage renal disease on dialysis.
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CLINICAL_TRIALS trial_result · 2020-01-13Clinical Trial Update: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease [Phase 3]
Phase 3 randomized trial evaluating ferric citrate in subjects with hyperphosphatemia and end-stage renal disease (ESRD) has completed.
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CLINICAL_TRIALS trial_result · 2020-01-02Clinical Trial Update: A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis [Phase 2]
Phase 2 trial assessing pharmacokinetics and comparing lanthanum carbonate to calcium carbonate for efficacy and safety in hyperphosphatemic…
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CLINICAL_TRIALS trial_result · 2019-08-28Clinical Trial Update: A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia [Phase 3]
A Phase 3 pediatric CKD trial comparing Velphoro (PA21) and Phoslyra (calcium acetate) for hyperphosphatemia was terminated with results pos…
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FDA approval · 2019-02-08FDA Approved: SEVELAMER HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Sevelamer hydrochloride as a generic product under an original ANDA from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2018-11-08FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) submitted by Takeda, resulting in updated labeling for managing h…
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FDA approval · 2018-11-08FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Fosrenol (lanthanum carbonate) from Takeda Pharmaceuticals America, Inc. The update pertains…
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FDA approval · 2018-10-25FDA Approved: SEVELAMER CARBONATE FOR ORAL SUSPENSION — Original Application (Dr. Reddys Laboratories Inc)
FDA approved an original ANDA for Sevelamer carbonate for oral suspension from Dr. Reddy's Laboratories Inc.
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CLINICAL_TRIALS trial_result · 2018-10-09Clinical Trial Update: A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia [Phase 3]
Phase III study of PA21 in hemodialysis patients with hyperphosphatemia has completed; results posted in 2018.
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CLINICAL_TRIALS trial_result · 2018-10-09Clinical Trial Update: A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia [Phase 3]
Phase III trial update for PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia; study completed with results posted …
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CLINICAL_TRIALS trial_result · 2018-08-01Clinical Trial Update: Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D [Phase 3]
Phase 3 trial update for ferric citrate in transitioning from CKD stages 4/5 to 5D; study completed.
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CLINICAL_TRIALS trial_result · 2018-05-31Clinical Trial Update: Behavioral Management of Phosphorus in Hemodialysis Patients [NA]
This clinical trial update reports completion of a study evaluating behavioral strategies to manage phosphorus levels in hemodialysis patien…
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FDA approval · 2018-04-25FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)
The FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) submitted by Fresenius Medical Care Renal Therapies Grou…
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EMA withdrawal · 2018-03-27EMA Lapsed: Tasermity (sevelamer hydrochloride) — Genzyme Europe BV
EMA has lapsed the marketing authorization for Tasermity (sevelamer hydrochloride) by Genzyme Europe BV for hyperphosphatemia and renal dial…
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FDA approval · 2018-03-20FDA Approved: SEVELAMER CARBONATE — Original Application (Westminster Pharmaceuticals, LLC)
FDA approved Westminster Pharmaceuticals' sevelamer carbonate generic (ANDA200959) for controlling serum phosphorus in adults with chronic k…
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CLINICAL_TRIALS trial_result · 2018-02-26Clinical Trial Update: Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients [NA]
Clinical trial update indicating the study on individualized therapy for hyperphosphatemia in maintenance hemodialysis patients has complete…
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FDA approval · 2017-11-28FDA Approved: SEVELAMER CARBONATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals’ generic Sevelamer carbonate (Original Application) for the treatment of hyperphosphatemia in adults wit…
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FDA approval · 2017-10-26FDA Approved: SEVELAMER CARBONATE — Original Application (Exelan Pharmaceuticals Inc.)
FDA approved a generic version of sevelamer carbonate (Sevelamer carbonate) from Exelan Pharmaceuticals Inc. for the treatment of hyperphosp…
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FDA approval · 2017-09-29FDA Approved: SEVELAMER CARBONATE — Original Application (DR. REDDY'S LABORATORIES LIMITED)
FDA approved the Sevelamer carbonate original application (ANDA206094) from Dr. Reddy's Laboratories Limited for the treatment of hyperphosp…