Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-01-03FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)
FDA approved a supplemental application for REPATHA (evolocumab) submitted by Amgen USA Inc.
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CLINICAL_TRIALS trial_result · 2017-01-02Clinical Trial Update: Prevention Trial to Achieve Cardiovascular Targets [NA]
This clinical trial update reports the completion of the Prevention Trial to Achieve Cardiovascular Targets (NCT01642355). The trial examine…
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FDA approval · 2016-12-20FDA Approved: PITAVASTATIN — Original Application (Aurobindo Pharma Limited)
FDA approved the original Abbreviated New Drug Application for pitavastatin from Aurobindo Pharma Limited, enabling the generic to enter the…
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FDA approval · 2016-12-15FDA Approved: FENOFIBRATE — Original Application (Cipla USA Inc.)
This FDA entry records Cipla USA Inc.'s original approval of a generic fenofibrate tablet for lipid disorders.
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CLINICAL_TRIALS trial_result · 2016-12-12Clinical Trial Update: Study of the Long-term Effects of Exercise on Heath Indicators in Older People [NA]
A completed clinical trial update reporting the long-term effects of exercise on health indicators in older adults, including hypertension, …
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CLINICAL_TRIALS research · 2016-12-02Clinical Trial Update: A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia [Phase 2, Phase 3]
This clinical trial update compares rosuvastatin and atorvastatin in patients with hyperlipidemia across Phase 2 and Phase 3; no results or …
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FDA approval · 2016-11-29FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin Pharmaceuticals' supplemental application for fenofibrate, indicating an approved labeling update or new indication under…
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FDA approval · 2016-11-23FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)
FDA approved Cadila Pharmaceuticals' rosuvastatin calcium as an original generic product (ANDA 207453) for lowering cholesterol.
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FDA approval · 2016-11-20FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for pravastatin sodium from Aurobindo Pharma Limited (ANDA077793), authorizing continued marketing o…
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FDA approval · 2016-11-17FDA Approved: PRAVASTATIN SODIUM — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's pravastatin sodium product via an Original Application (ANDA207068).
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FDA approval · 2016-11-09FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for fenofibrate filed by Lupin Pharmaceuticals, Inc. under NDA 021695. The approval updates the feno…
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CLINICAL_TRIALS trial_result · 2016-11-09Clinical Trial Update: Pilot Study Testing Feasibility of Health Screening at Farm Site [NA]
A completed pilot study assessed the feasibility of conducting diabetes, hyperlipidemia, and hypertension health screening at a farm site.
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cranbury Pharmaceuticals, LLC)
FDA approved Cranbury Pharmaceuticals' rosuvastatin calcium through an Original Application for an Abbreviated New Drug Application (ANDA), …
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's original application for rosuvastatin as a generic product. Rosuvastatin is used to treat hyperlipidemia an…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approved an Original Application for rosuvastatin calcium from Torrent Pharmaceuticals Limited, granting generic approval for the rosuva…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves rosuvastatin (generic) under an Original Application by Camber Pharmaceuticals, adding a generic statin option for lowering cho…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved an original ANDA for rosuvastatin calcium, enabling a generic version of rosuvastatin calcium manufactured by Puracap Laborator…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Westminster Pharmaceuticals, LLC)
FDA approved the Original Application for rosuvastatin calcium from Westminster Pharmaceuticals, LLC, granting a generic rosuvastatin calciu…
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CLINICAL_TRIALS trial_result · 2016-10-27Clinical Trial Update: Lipoprotein Turnover on Low- and High-MUFA Portfolio Diets [Phase 2]
Phase 2 clinical trial evaluating lipoprotein turnover on low- versus high-MUFA diets in individuals with hyperlipidemia and cardiovascular …
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CLINICAL_TRIALS trial_result · 2016-10-21Clinical Trial Update: Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers [Phase 1]
Phase 1 pharmacokinetics and safety study of HCP1105 with co-administration of HGP0918 and HGP0816 in healthy male volunteers, sponsored by …
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CLINICAL_TRIALS trial_result · 2016-10-20Clinical Trial Update: Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia [Phase 3]
Phase 3 trial evaluating co-administered HGP0904, HGP0608, and HGP0816 in hypertension and hyperlipidemia has completed. The entry notes the…
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CLINICAL_TRIALS trial_result · 2016-10-20Clinical Trial Update: Reducing Risk of Recurrence [NA]
A VA-sponsored clinical trial to reduce recurrence risk after stroke or transient ischemic attack has completed, with results posted in 2016…
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CLINICAL_TRIALS trial_result · 2016-10-12Clinical Trial Update: Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia [Phase 3]
A Phase 3 trial evaluating morning versus evening dosing of simvastatin controlled-release for hyperlipidemia has completed, with focus on e…
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FDA approval · 2016-10-03FDA Approved: GEMFIBROZIL — Supplemental Application (NorthStar Rx LLC)
FDA approves a supplemental application for Gemfibrozil from NorthStar Rx LLC under an approved ANDA.
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FDA approval · 2016-10-03FDA Approved: GEMFIBROZIL — Supplemental Application (Chartwell RX, LLC)
This document indicates FDA approval of a supplemental ANDA for Gemfibrozil from Chartwell RX, LLC.