Hyperparathyroidism
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-02-11FDA Approved: PARSABIV — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for PARSABIV (etelcalcetide) from Amgen, Inc., updating the labeling as part of the supplemental sub…
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FDA approval · 2020-12-04FDA Approved: CINACALCET — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for cinacalcet submitted by Aurobindo Pharma Limited.
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FDA label_change · 2020-12-04FDA Approved: CINACALCET — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for cinacalcet (Cipla USA Inc.), resulting in changes to CINACALCET's labeling.
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FDA approval · 2020-12-04FDA Approved: CINACALCET — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Cinacalcet from Sun Pharmaceutical Industries, enabling an additional regulatory action for the …
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FDA approval · 2020-12-04FDA Approved: CINACALCET — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Cinacalcet from Ascend Laboratories, LLC, granting approval of a generic cinacalcet product unde…
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FDA approval · 2020-10-07FDA Approved: CINACALCET — Original Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' original application for a generic cinacalcet hydrochloride product.
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FDA approval · 2020-09-15FDA Approved: DOXERCALCIFEROL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approves an original ANDA for doxercalciferol (generic) manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2020-06-09Clinical Trial Update: Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients [Phase 4]
Phase 4 trial updating the effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients with secondary hyperparathyroidism.
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FDA approval · 2020-05-18FDA Approved: CINACALCET — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for CINACALCET submitted by Strides Pharma Science Limited under ANDA209226, enabling a suppleme…
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FDA approval · 2020-05-14FDA Approved: CINACALCET — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental ANDA for Cinacalcet from Aurobindo Pharma Limited, expanding access to a generic version of the drug.
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FDA approval · 2020-04-02FDA Approved: CINACALCET — Supplemental Application (Cipla USA Inc.)
FDA approved Cipla USA Inc.'s supplemental application for cinacalcet under ANDA 208915. The approval authorizes the continued marketing of …
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CLINICAL_TRIALS trial_result · 2020-03-09Clinical Trial Update: SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis [Phase 3]
Phase 3 long-term treatment study for secondary hyperparathyroidism in hemodialysis patients has completed.
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CLINICAL_TRIALS trial_result · 2020-03-09Clinical Trial Update: Phase 3 Study of SK-1403 [Phase 3]
Phase 3 trial update for SK-1403 in secondary hyperparathyroidism has completed.
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CLINICAL_TRIALS trial_result · 2020-02-10Clinical Trial Update: A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416 [Phase 1]
Phase 1 study evaluating pharmacokinetics, safety, and tolerability of AMG 416 in secondary hyperparathyroidism has completed with results p…
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FDA approval · 2020-02-07FDA Approved: DOXERCALCIFEROL — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approves the original ANDA for doxercalciferol, a generic vitamin D analog from Meitheal Pharmaceuticals, for the treatment of secondary…
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FDA label_change · 2019-10-17FDA Approved: PARICALCITOL — Supplemental Application (Accord Healthcare, Inc.)
The FDA approved a supplemental application for paricalcitol from Accord Healthcare, resulting in a label change for this chronic kidney dis…
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FDA approval · 2019-09-26FDA Approved: DOXERCALCIFEROL — Original Application (Gland Pharma Limited)
FDA approved Gland Pharma Limited's original application for a generic doxercalciferol product.
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FDA approval · 2019-07-24FDA Approved: PARICALCITOL — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for paricalcitol from Eugia US LLC. Paricalcitol is a vitamin D analog used to treat secondary h…
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CLINICAL_TRIALS trial_result · 2019-07-10Clinical Trial Update: A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis [Phase 1]
Phase 1 single-dose pediatric study in 2 to <18-year-olds with secondary hyperparathyroidism on haemodialysis (completed; results posted 201…
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FDA approval · 2019-05-17FDA Approved: CINACALCET — Original Application (Ascend Laboratories, LLC)
FDA approved a generic cinacalcet product from Ascend Laboratories for treating secondary hyperparathyroidism in adults with chronic kidney …
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CLINICAL_TRIALS trial_result · 2019-04-16Clinical Trial Update: Vitamin D Repletion in Primary Hyperparathyroidism [Phase 4]
Phase 4 clinical trial evaluating vitamin D repletion in patients with primary hyperparathyroidism and vitamin D deficiency; study completed…
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CLINICAL_TRIALS trial_result · 2019-03-15Clinical Trial Update: Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism [Phase 2]
Phase 2 dose adjustment trial of SK-1403 in hemodialysis patients with secondary hyperparathyroidism has completed.
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FDA approval · 2019-03-08FDA Approved: PARSABIV — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for Parsabiv (etelcalcetide) from Amgen, Inc. The document records the agency's action on Amgen's su…
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FDA approval · 2019-02-21FDA Approved: CALCITRIOL — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a generic calcitriol product from Sun Pharmaceutical Industries under an original ANDA, enabling another generic calcitriol opt…
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CLINICAL_TRIALS research · 2018-12-20Clinical Trial Update: Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity [Phase 4]
Phase 4 trial update characterizing vitamin D deficiency and secondary hyperparathyroidism in obesity.