Hyperparathyroidism
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Sign up freeTop drugs studied for this disease
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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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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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FDA approval · 2018-10-11FDA Approved: CINACALCET — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved cinacalcet (Sun Pharmaceutical) via an original application; the generic CINACALCET is approved for secondary hyperparathyroidi…
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FDA approval · 2018-10-09FDA Approved: PARICALCITOL — Original Application (Eugia US LLC)
FDA approved the original ANDA for paricalcitol from Eugia US LLC, a vitamin D receptor activator, for the treatment of secondary hyperparat…
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FDA approval · 2018-08-20FDA Approved: PARSABIV — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for Parsabiv (etelcalcetide) from Amgen, updating the product labeling. The action relates to tr…
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FDA approval · 2018-03-08FDA Approved: CINACALCET — Original Application (Cipla USA Inc.)
FDA approved Cipla USA Inc.'s generic cinacalcet (cinacalcet) under an original ANDA for its approved indications: secondary hyperparathyroi…
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FDA approval · 2017-05-23FDA Approved: SENSIPAR — Supplemental Application (Amgen Inc)
FDA approved a supplemental application for Sensipar (cinacalcet hydrochloride) from Amgen Inc, relating to labeling changes for the drug.
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FDA approval · 2017-03-09FDA Approved: PARICALCITOL — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's original ANDA for PARICALCITOL, a generic paricalcitol product for treating secondary hyperparathy…
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EMA approval · 2017-02-24First hormone replacement therapy for parathyroid disorder
The European Medicines Agency announces the first hormone replacement therapy for a parathyroid disorder, marking a new treatment option.
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FDA approval · 2017-02-07FDA Approved: PARSABIV — Original Application (Amgen, Inc)
FDA approved PARSABIV (etelcalcetide) in an Original Application (NDA 208325) by Amgen, Inc for the treatment of secondary hyperparathyroidi…
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FDA approval · 2016-12-14FDA Approved: RAYALDEE — Supplemental Application (OPKO Pharmaceuticals LLC)
FDA approved a supplemental application for RAYALDEE (calcifediol) from OPKO Pharmaceuticals LLC.
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FDA approval · 2016-10-18FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for ZEMPLAR (paricalcitol) submitted by AbbVie Inc.
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FDA approval · 2016-10-07FDA Approved: PARICALCITOL — Original Application (MARKSANS PHARMA LIMITED)
The FDA has approved an original application for a generic paricalcitol from Marksans Pharma Limited. Paricalcitol is a vitamin D analog use…
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FDA approval · 2016-06-17FDA Approved: RAYALDEE — Original Application (OPKO Pharmaceuticals LLC)
The FDA approved RAYALDEE (calcifediol) from OPKO Pharmaceuticals as a new drug for adults with stage 3–4 chronic kidney disease and hypocal…
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FDA approval · 2016-02-04FDA Approved: PARICALCITOL — Original Application (Accord Healthcare, Inc.)
FDA approved Accord Healthcare, Inc.'s paricalcitol under its original application NDA207174 for the treatment of secondary hyperparathyroid…
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FDA approval · 2016-01-14FDA Approved: PARICALCITOL — Original Application (Aurobindo Pharma Limited)
The FDA approved the original application (ANDA) for paricalcitol from Aurobindo Pharma Limited. This generic paricalcitol is used to treat …
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FDA approval · 2016-01-13FDA Approved: PARICALCITOL — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal's original application for generic paricalcitol (PARICALCITOL), a vitamin D analog used to treat secondary hyperparathyr…
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FDA approval · 2015-08-18FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
The FDA approved AbbVie’s supplemental application for ZEMPLAR (paricalcitol). The action updates the labeling and/or indications for this p…
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FDA approval · 2015-05-27FDA Approved: PARICALCITOL — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for PARICALCITOL from Dr. Reddy's Laboratories Limited.
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FDA approval · 2014-12-12FDA Approved: CALCITRIOL — Original Application (Chartwell RX, LLC)
FDA approved Calcitriol capsules (0.25 mcg and 0.5 mcg) from Chartwell RX, LLC through an Original Application, granting a generic version o…
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FDA approval · 2014-11-18FDA Approved: PARICALCITOL — Original Application (West-Ward Pharmaceuticals Corp)
FDA approved paricalcitol under an original NDA from West-Ward Pharmaceuticals Corp for the management of secondary hyperparathyroidism in a…
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FDA approval · 2014-06-24FDA Approved: PARICALCITOL — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved the original application for paricalcitol from Dr. Reddy's Laboratories Limited, enabling a generic version of the drug. This m…
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FDA approval · 2014-03-27FDA Approved: PARICALCITOL — Original Application (Bionpharma Inc.)
FDA approved Bionpharma Inc.'s original application for paricalcitol, a generic paricalcitol product. This approval supports the use of pari…
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FDA approval · 2013-10-17FDA Approved: ZEMPLAR — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for ZEMPLAR (paricalcitol) submitted by AbbVie Inc., indicating an approved update to its labeling/i…