Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS withdrawal · 2019-01-11Clinical Trial Update: Effects of a Supplement Derived From Palm Oil on Cholesterol Levels and Chinese Red Yeast Rice in the Blood [Phase 2, Phase 3]
A Phase 2/3 clinical trial investigating a palm-oil-derived supplement and Chinese red yeast rice for cholesterol lowering was withdrawn.
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CLINICAL_TRIALS trial_result · 2019-01-07Clinical Trial Update: Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors. [Phase 2]
Phase 2 clinical trial exploring red-fleshed apple as an anthocyanin-biofortified food to improve cardiometabolic risk factors in individual…
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FDA approval · 2018-12-31FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin from NorthStar Rx LLC, updating the approved generic product's labeling/manufacturin…
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FDA approval · 2018-12-31FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for SIMVASTATIN from Accord Healthcare, Inc., updating the approved product. This action concerns a …
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FDA approval · 2018-12-21FDA Approved: ATORVASTATIN CALCIUM — Original Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' atorvastatin calcium as an original generic application, authorizing a new generic version of atorvast…
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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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FDA approval · 2018-12-13FDA Approved: GEMFIBROZIL — Supplemental Application (Cadila Pharmaceuticals Limited)
FDA approved a supplemental application for gemfibrozil filed by Cadila Pharmaceuticals Limited, changing the labeling of this generic lipid…
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FDA approval · 2018-12-11FDA Approved: GEMFIBROZIL — Supplemental Application (Northstar RxLLC)
FDA approved a supplemental application for gemfibrozil under an existing ANDA held by Northstar RxLLC.
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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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CLINICAL_TRIALS trial_result · 2018-11-20Clinical Trial Update: Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C [Phase 1]
Phase I safety and PK/PD study of lomitapide in Japanese and Caucasian subjects with elevated LDL-C completed; results posted in 2018.
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CLINICAL_TRIALS trial_result · 2018-11-15Clinical Trial Update: Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals [Phase 2]
Phase 2 clinical trial investigating whether fibre viscosity predicts cholesterol-lowering effects in healthy individuals.
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FDA approval · 2018-11-07FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for fenofibrate from Lupin Pharmaceuticals, Inc.
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FDA approval · 2018-11-07FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for Fenofibric Acid from Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2018-10-26FDA Approved: EZETIMIBE — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s original ANDA for a generic ezetimibe product, authorizing its marketing as a cholesterol-lowering tre…
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FDA approval · 2018-10-05FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Dr.Reddys Laboratories Inc)
FDA approved a generic Colesevelam Hydrochloride (colesevelam hydrochloride) via an Original Application filed by Dr. Reddy's Laboratories I…
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FDA approval · 2018-10-05FDA Approved: COLESEVELAM HCL — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' Colesevelam HCl (generic) under ANDA209038. The drug is a bile acid sequestrant indicated to reduce LDL ch…
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CLINICAL_TRIALS trial_result · 2018-09-21Clinical Trial Update: Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk [NA]
Clinical trial update for Prioritized Clinical Decision Support (CDS) aimed at reducing cardiovascular risk; the study with hypertension and…
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FDA approval · 2018-09-12FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
The FDA granted supplemental approval for the fixed-dose combination of amlodipine besylate and atorvastatin calcium by Prasco Laboratories.
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FDA approval · 2018-09-10FDA Approved: FENOFIBRATE — Original Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s original ANDA for fenofibrate, a generic lipid-lowering medication.
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CLINICAL_TRIALS trial_result · 2018-09-07Clinical Trial Update: Clinical Trial to Evaluate the Efficacy and Safety of YHP1701 [Phase 3]
Phase 3 clinical trial evaluating the efficacy and safety of YHP1701 for hypertension and hyperlipidemia has been completed.
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FDA approval · 2018-08-28FDA Approved: FENOFIBRATE — Original Application (Solco Healthcare US, LLC)
FDA approved the original application for fenofibrate (generic) from Solco Healthcare US, LLC, authorizing its use for certain lipid disorde…
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FDA approval · 2018-08-28FDA Approved: GEMFIBROZIL — Original Application (Zydus Lifesciences Limited)
FDA approved the original ANDA for Gemfibrozil from Zydus Lifesciences Limited, making a generic fibrate available in the United States.
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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 · 2018-08-21Clinical Trial Update: Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia [Phase 3]
Phase 3 trial updating safety and efficacy evaluation of CJ-30061 in patients with hypertension and hyperlipidemia.
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FDA approval · 2018-08-17FDA Approved: FENOFIBRATE — Original Application (Leading Pharma, LLC)
FDA approved Leading Pharma, LLC's original Abbreviated New Drug Application for fenofibrate, enabling marketing of a generic fenofibrate pr…