Mixed Dyslipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-09-07FDA Approved: FENOFIBRATE — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries, Inc.'s original ANDA for fenofibrate (generic fenofibrate).
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FDA approval · 2017-08-25FDA Approved: EZETIMIBE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for ezetimibe from Aurobindo Pharma Limited, enabling a generic version of the cholesterol-lowering dr…
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FDA approval · 2017-08-04FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin Pharmaceuticals' supplemental application for Lovastatin (generic statin). The approval pertains to changes under the AND…
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FDA approval · 2017-06-12FDA Approved: EZETIMIBE — Original Application (Sandoz Inc)
FDA approved Sandoz Inc's original application for ezetimibe, a generic cholesterol-lowering medication. The approval confirms marketing aut…
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CLINICAL_TRIALS trial_result · 2017-05-17Clinical Trial Update: Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events [Phase 3]
Phase 3 randomized trial evaluating bococizumab in subjects with hyperlipidemia or mixed dyslipidemia at risk of cardiovascular events has c…
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FDA approval · 2017-04-26FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Dr.Reddys Laboratories Inc)
FDA approved a new generic fixed-dose combination of ezetimibe and simvastatin from Dr. Reddy's Laboratories Inc under an Original Applicati…
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CLINICAL_TRIALS trial_result · 2017-02-23Clinical Trial Update: Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia [Phase 3]
This entry notes the completion of a Phase 3 trial evaluating different doses of fluvastatin for efficacy and safety in adults with mixed dy…
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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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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 · 2016-10-03FDA 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 · 2016-09-07FDA Approved: FENOFIBRIC ACID — Original Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved Amneal Pharmaceuticals of New York LLC's fenofibric acid under an original ANDA for treatment of lipid disorders including …
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CLINICAL_TRIALS trial_result · 2016-08-31Clinical Trial Update: Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody [Phase 3]
Phase 3 trial evaluating effects on lipoprotein metabolism from PCSK9 inhibition using a monoclonal antibody in primary hyperlipidemia and m…
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FDA approval · 2016-07-19FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved an original Abbreviated New Drug Application for rosuvastatin calcium from Rising Pharma Holdings, Inc.
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FDA approval · 2016-06-23FDA Approved: FENOFIBRATE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved the original generic application for fenofibrate from Mylan Pharmaceuticals Inc., enabling the marketing of a fenofibrate produ…
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CLINICAL_TRIALS trial_result · 2016-06-21Clinical Trial Update: Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143) [Phase 3]
A Phase 3 trial evaluating an extended-release combination tablet of niacin, laropiprant, and simvastatin in individuals with primary hyperc…
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FDA approval · 2016-05-19FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s atorvastatin calcium tablet as an Original Application, enabling a generic atorvastatin calcium product to…
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FDA approval · 2016-05-05FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)
FDA approves the original application (ANDA) for Fenofibrate manufactured by Aurobindo Pharma Limited, authorizing its generic fenofibrate p…
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CLINICAL_TRIALS trial_result · 2016-04-01Clinical Trial Update: MK-0524B Lipid Study (MK-0524B-063) [Phase 3]
A Phase 3 clinical trial of MK-0524B for primary hypercholesterolemia and mixed dyslipidemia has completed, with results posted in 2016.
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CLINICAL_TRIALS trial_result · 2016-01-29Clinical Trial Update: Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab [Phase 1]
Phase 1 pharmacokinetic study assessing the impact of severe renal impairment and dialysis on evolocumab.
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FDA approval · 2015-12-23FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for LIPOFEN (fenofibrate) submitted by ANI Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2015-12-23Clinical Trial Update: Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen [Phase 3]
Phase 3 trial assessing in-home administration of evolocumab (AMG 145) using automated mini-doser or prefilled autoinjector/pen in patients …
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FDA approval · 2015-11-18FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for Fenofibric Acid submitted by Amneal Pharmaceuticals of New York LLC.
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CLINICAL_TRIALS trial_result · 2015-10-09Clinical Trial Update: Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen [Phase 3]
Phase 3 trial assessing in-home use of evolocumab via prefilled syringe or autoinjector; completed with posted results.
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FDA approval · 2015-04-17FDA 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, resulting in a change to its ap…