Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-04-03FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cranbury Pharmaceuticals, LLC)
FDA approved Cranbury Pharmaceuticals, LLC's supplemental application for Rosuvastatin Calcium, authorizing a generic rosuvastatin calcium p…
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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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CLINICAL_TRIALS trial_result · 2019-03-29Clinical Trial Update: A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes [Phase 2]
Phase 2 clinical trial evaluating ETC 1002 for efficacy and safety in subjects with Type 2 Diabetes; study completed.
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CLINICAL_TRIALS trial_result · 2019-03-29Clinical Trial Update: A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg [Phase 2]
Phase 2 trial evaluating pharmacokinetics, pharmacodynamics, and safety of adding ETC-1002 to atorvastatin 80 mg in hyperlipidemia.
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FDA approval · 2019-03-28FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC.
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FDA label_change · 2019-03-27FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) by Sun Pharmaceutical Industries, Inc., related to this rosu…
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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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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 · 2019-03-01FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental ANDA for fenofibrate from Amneal Pharmaceuticals NY LLC, authorizing changes to the approved generic product…
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CLINICAL_TRIALS trial_result · 2019-02-25Clinical Trial Update: A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol [Phase 1]
Phase 1 trial update for LY3015014 in otherwise healthy participants with high LDL cholesterol has completed; results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-02-20Clinical Trial Update: DYNAMIC Study: (Diabetes Nurse Case Management And Motivational Interviewing for Change) [Phase 3]
Completed Phase 3 clinical trial evaluating diabetes nurse case management and motivational interviewing for change in adults with diabetes,…
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FDA approval · 2019-02-19FDA Approved: GEMFIBROZIL — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for gemfibrozil by NorthStar Rx LLC.
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CLINICAL_TRIALS trial_result · 2019-02-18Clinical Trial Update: Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction [Phase 2]
Phase 2 study evaluating LIB003 for additional LDL-C reduction in patients on lipid-lowering therapy has completed. The trial assessed effic…
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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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CLINICAL_TRIALS trial_result · 2019-02-15Clinical Trial Update: Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002 [Phase 1]
Phase 1 single radiolabeled dose study to characterize absorption, metabolism, and excretion of [14C]-ETC-1002. The trial has completed.
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CLINICAL_TRIALS trial_result · 2019-02-11Clinical Trial Update: Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood [Phase 4]
A Phase 4 exploratory trial assessed the effects of omega-3-acid ethyl esters on lipid and lipoprotein profiles in hyperlipidemia; results w…
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FDA approval · 2019-02-11FDA Approved: FENOFIBRATE — Original Application (Chartwell RX, LLC)
FDA approved Chartwell RX, LLC's original application for a generic fenofibrate product used to treat hyperlipidemia, hypertriglyceridemia, …
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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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FDA approval · 2019-02-04FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate (NDA021695), a generic fenofibrate product.
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CLINICAL_TRIALS trial_result · 2019-01-31Clinical Trial Update: Rosuvastatin Adherence App Study in China [NA]
AstraZeneca-sponsored clinical trial in China evaluating a rosuvastatin adherence app for dyslipidemia/hyperlipidemia has completed, with re…
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CLINICAL_TRIALS trial_result · 2019-01-16Clinical Trial Update: Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia [Phase 3]
Phase 3 clinical trial evaluating Temisartan/Amlodipine with Rosuvastatin in hypertension and hyperlipidemia has completed. The update does …
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CLINICAL_TRIALS trial_result · 2019-01-16Clinical Trial Update: Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin [Phase 1]
Phase 1 trial update on the safety and pharmacokinetics of YHP1604 compared to the co-administration of Telmisartan/Amlodipine and Rosuvasta…
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CLINICAL_TRIALS trial_result · 2019-01-11Clinical Trial Update: Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia [Phase 3]
Phase 3 trial evaluating evolocumab in combination with statin therapy in adults with diabetes and hyperlipidemia or mixed dyslipidemia; com…