Hyperaldosteronism
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CLINICAL_TRIALS research · 2024-04-26Clinical Trial Update: Preoperative Supine Time for Adrenal Venous Sampling [NA]
A clinical trial update notes a recruiting study examining preoperative supine time for adrenal venous sampling in patients with primary hyp…
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FDA approval · 2023-10-10FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for spironolactone by Mylan Pharmaceuticals Inc., updating the approval for this generic diuretic. T…
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FDA approval · 2023-09-05FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved the original ANDA for spironolactone from Amneal Pharmaceuticals NY LLC, enabling a generic version of the diuretic.
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FDA approval · 2023-08-24FDA Approved: SPIRONOLACTONE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for spironolactone from Padagis US LLC, indicating an updated regulatory action on this product (sup…
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FDA approval · 2023-06-28FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Spironolactone from Amneal Pharmaceuticals LLC.
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FDA approval · 2023-06-23FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)
FDA approved a supplemental application for spironolactone by Oxford Pharmaceuticals, LLC. The approval allows continued marketing of the ge…
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CLINICAL_TRIALS trial_result · 2023-04-18Clinical Trial Update: Effect of MRA on Cardiovascular Disease in Patients With Hypertension and Hyperaldosteronemia [Phase 4]
Phase 4 clinical trial evaluating the effect of mineralocorticoid receptor antagonist (MRA) on cardiovascular disease in patients with hyper…
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FDA approval · 2021-02-26FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for spironolactone from Mylan Pharmaceuticals, resulting in changes to the product labeling as p…
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FDA approval · 2021-02-26FDA Approved: SPIRONOLACTONE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Accord Healthcare's generic spironolactone. This action confirms approval of modifications under…
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FDA approval · 2021-02-26FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)
The FDA approved a supplemental application for spironolactone from Oxford Pharmaceuticals, LLC, under the existing ANDA.
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FDA approval · 2019-11-14FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for spironolactone from Mylan Pharmaceuticals Inc., enabling continued marketing of the product and …
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FDA approval · 2019-11-14FDA Approved: SPIRONOLACTONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA has approved a supplemental application for spironolactone from Jubilant Cadista Pharmaceuticals Inc. under the ANDA framework.
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FDA approval · 2019-08-05FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application for spironolactone, enabling the marketing of a new generic product.
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FDA approval · 2019-07-25FDA Approved: SPIRONOLACTONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for spironolactone submitted by Sun Pharmaceutical Industries, Inc., indicating an update to the…
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FDA approval · 2018-07-18FDA Approved: SPIRONOLACTONE — Original Application (Zydus Lifesciences Limited)
FDA approved the Original Application (ANDA) for spironolactone from Zydus Lifesciences Limited, marking a generic version of the diuretic.
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CLINICAL_TRIALS trial_result · 2017-10-12Clinical Trial Update: Primary Hyperaldosteronism and Ischemia-reperfusion Injury [NA]
A completed clinical trial at Radboud University Medical Center investigated primary hyperaldosteronism and ischemia-reperfusion injury.
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CLINICAL_TRIALS trial_result · 2017-04-25Clinical Trial Update: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation [NA]
A clinical trial comparing laparoscopic adrenalectomy to radiofrequency ablation for hyperaldosteronism due to an adrenocortical adenoma (Co…
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CLINICAL_TRIALS trial_result · 2016-10-19Clinical Trial Update: Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism
A completed clinical trial evaluating myocardial interstitial fibrosis in people with primary or secondary hyperaldosteronism.
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CLINICAL_TRIALS research · 2016-10-18Clinical Trial Update: Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study
A nationwide multicenter study in Malaysia is investigating primary hyperaldosteronism. The current status of the study is unknown.
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FDA approval · 2016-09-19FDA Approved: SPIRONOLACTONE — Original Application (Accord Healthcare, Inc.)
FDA approves Accord Healthcare, Inc.'s original application for spironolactone (generic), authorizing its use as a potassium-sparing diureti…
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CLINICAL_TRIALS trial_result · 2016-04-06Clinical Trial Update: Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment
A completed clinical trial from Radboud University Medical Center examining organ damage, epidemiology, and treatment of primary aldosteroni…
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FDA approval · 2015-04-26FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Spironolactone from Mylan Pharmaceuticals Inc., indicating an approved change to an already-appr…
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FDA approval · 2014-04-23FDA Approved: SPIRONOLACTONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approved the original ANDA for spironolactone, authorizing a generic version manufactured by Jubilant Cadista Pharmaceuticals Inc.
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FDA approval · 2014-03-06FDA Approved: SPIRONOLACTONE — Original Application (NorthStar Rx LLC)
The FDA approved NorthStar Rx LLC's Original Application for spironolactone (generic spironolactone).
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CLINICAL_TRIALS trial_result · 2014-01-15Clinical Trial Update: Etiology of Sleep Apnea-related Hyperaldosteronism - BP Treatment [NA]
A completed trial investigating the causes of sleep apnea–related hyperaldosteronism and its impact on blood pressure treatment in patients …