Familial Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2019-05-13Clinical Trial Update: Effect of Omega-3 Fatty Acid on Endothelial Function [Phase 3]
Phase 3 trial update on omega-3 fatty acids evaluating endothelial function in familial hypercholesterolemia.
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FDA approval · 2019-05-07FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Shandong New Time Pharmaceutical Co., Ltd.)
FDA approved the original application for rosuvastatin calcium (generic rosuvastatin) from Shandong New Time Pharmaceutical Co., Ltd., expan…
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FDA label_change · 2019-04-26FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
FDA approved a supplemental application for PRALUENT (alirocumab) from Regeneron, updating the product labeling to reflect new information.
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FDA approval · 2019-04-24FDA Approved: ROSUVASTATIN — Original Application (ScieGen Pharmaceuticals, Inc.)
FDA approved the original ANDA for a generic rosuvastatin product, manufactured by ScieGen Pharmaceuticals, Inc.
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FDA approval · 2019-04-12FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC.
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FDA approval · 2019-04-02FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.
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FDA approval · 2019-03-22FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approves a supplemental application for the ezetimibe and simvastatin combination by Amneal, indicating a modification to an already-app…
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CLINICAL_TRIALS trial_result · 2019-03-14Clinical Trial Update: A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol [Phase 3]
Phase 3 trial evaluating two regimens of mipomersen in patients with familial hypercholesterolemia and inadequately controlled LDL cholester…
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FDA approval · 2019-03-06FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)
FDA approved Biocon Pharma Inc.'s supplemental application for simvastatin (ANDA 078034). The approval concerns Biocon's generic simvastatin…
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FDA approval · 2019-03-06FDA Approved: ATORVASTATIN CALCIUM — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc. for atorvastatin calcium as a generic product under an Original Application (ANDA).
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FDA approval · 2019-03-01FDA Approved: ROSUVASTATIN — Original Application (AiPing Pharmaceutical, Inc.)
The FDA approved AiPing Pharmaceutical, Inc.'s rosuvastatin as a generic product under an original application, enabling marketing of this s…
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FDA approval · 2019-02-15FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)
FDA approved a supplemental application for REPATHA (evolocumab) filed by Amgen USA Inc., resulting in labeling updates.
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FDA approval · 2019-02-08FDA Approved: ATORVASTATIN CALCIUM — Original Application (Novadoz Pharmaceuticals LLC)
FDA approves the first original application for atorvastatin calcium as a generic product from Novadoz Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2019-01-28Clinical Trial Update: Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders [Phase 2, Phase 3]
Amgen’s long-term trial of a PCSK9 inhibitor in subjects with familial hypercholesterolemia has completed Phase 2/Phase 3 and results have b…
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FDA approval · 2018-12-18FDA Approved: EZALLOR SPRINKLE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved EZALLOR SPRINKLE (rosuvastatin) under Sun Pharmaceutical Industries, Inc.'s Original Application, introducing a sprinkle-form r…
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CLINICAL_TRIALS trial_result · 2018-12-04Clinical Trial Update: A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833) [Phase 3]
A completed Phase 3 trial assessing the long-term safety and tolerability of MK-0653H in Japanese participants with hypercholesterolemia; re…
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FDA approval · 2018-11-20FDA Approved: ATORVASTATIN CALCIUM — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for atorvastatin calcium from Zydus Lifesciences Limited, granting generic approval for lowering chole…
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FDA approval · 2018-08-22FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
The FDA approved a supplemental application for PRALUENT (alirocumab) submitted by Regeneron Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2018-06-20Clinical Trial Update: Effects of Soy Protein on Cholesterol Levels in Children Affected With Familial Hypercholesterolemia [NA]
This completed clinical trial studied the effects of soy protein on cholesterol levels in children with heterozygous familial hypercholester…
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FDA approval · 2018-06-18FDA Approved: ATORVASTATIN CALCIUM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved Rising Pharma's generic atorvastatin calcium (original ANDA) for lowering cholesterol and reducing cardiovascular risk.
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FDA approval · 2018-05-21FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)
FDA has approved a supplemental application for ezetimibe from Ascend Laboratories, LLC, authorizing continued marketing under the ANDA.
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CLINICAL_TRIALS trial_result · 2018-05-11Clinical Trial Update: Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia [Phase 3]
Phase 3 long-term follow-on study of lomitapide in patients with homozygous familial hypercholesterolemia. Results from the completed study …
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CLINICAL_TRIALS research · 2018-03-12Clinical Trial Update: a Prospective Pilot Study of Screening Out Rate and Clinical Management of Familial Hypercholesterolemia
A prospective pilot study update on screening out rate and clinical management of Familial Hypercholesterolemia, sponsored by the China Card…
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FDA approval · 2018-02-28FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC. The action commonly updates labeling, indications,…
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CLINICAL_TRIALS trial_result · 2017-12-07Clinical Trial Update: Familial Hypercholesterolemia in Turkey (A-HIT2)
Completed clinical trial in Turkey (A-HIT2) investigating familial hypercholesterolemia and atherosclerosis. No specific drug names are list…