Hyperparathyroidism
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-18EMA Authorised: Parsabiv (etelcalcetide hydrochloride) — Amgen Europe B.V.
Parsabiv (etelcalcetide hydrochloride) has been authorized by EMA for secondary hyperparathyroidism.
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EMA approval · 2026-03-31EMA Authorised: Cinacalcet Accordpharma (cinacalcet hydrochloride) — Accord Healthcare S.L.U.
The EMA authorised Cinacalcet Accordpharma (cinacalcet hydrochloride) by Accord Healthcare S.L.U. for the treatment of hyperparathyroidism.
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FDA approval · 2026-03-23FDA Approved: CINACALCET — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for cinacalcet from Aurobindo Pharma Limited, allowing a generic version to be marketed.
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EMA approval · 2025-10-07EMA Authorised: Cinacalcet Viatris (previously Cinacalcet Mylan) (cinacalcet hydrochloride) — Mylan Pharmaceuticals Limited
EMA authorised Cinacalcet Viatris (cinacalcet hydrochloride) for secondary hyperparathyroidism and hypercalcemia, with Mylan Pharmaceuticals…
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EMA approval · 2024-06-07EMA Authorised: Parsabiv (etelcalcetide hydrochloride) — Amgen Europe B.V.
EMA authorized Parsabiv (etelcalcetide hydrochloride) by Amgen Europe B.V. for secondary hyperparathyroidism. The decision confirms EU marke…
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EMA approval · 2024-06-06EMA Authorised: Mimpara (cinacalcet hydrochloride) — Amgen Europe B.V.
The European Medicines Agency authorised Mimpara (cinacalcet hydrochloride) for indications including hypercalcemia, parathyroid neoplasms, …
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FDA approval · 2024-01-19FDA Approved: RAYALDEE — Supplemental Application (OPKO Pharmaceuticals LLC)
FDA approved a supplemental application for RAYALDEE (calcifediol) from OPKO Pharmaceuticals LLC under NDA 208010, authorizing changes to th…
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FDA approval · 2023-12-08FDA Approved: CINACALCET — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Accord Healthcare’s generic cinacalcet product. The approval confirms continued market availabil…
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FDA approval · 2023-07-28FDA Approved: CINACALCET — Supplemental Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's supplemental application for Cinacalcet, granting approval of a generic cinacalcet product.
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FDA approval · 2023-06-15FDA Approved: DOXERCALCIFEROL — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved an original application for doxercalciferol as a generic drug, expanding access to this vitamin D analog.
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FDA approval · 2022-01-24FDA Approved: DOXERCALCIFEROL — Original Application (Eugia US LLC)
FDA approved an original application for doxercalciferol (generic) by Eugia US LLC.
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FDA approval · 2021-12-02FDA Approved: CINACALCET HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal Pharmaceuticals' cinacalcet hydrochloride generic under an Original Application (ANDA), enabling a generic version of ci…
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FDA approval · 2021-03-02FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for ZEMPLAR (paricalcitol) submitted by AbbVie Inc.
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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 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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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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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 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…