Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-05-16FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, Inc.
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for fenofibrate from Lupin Pharmaceuticals, Inc. under the drug’s existing approval.
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FDA approval · 2019-05-15FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc., marking a regulatory action on thi…
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
The FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., extending regulatory approval for the generic …
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.,)
FDA approved a supplemental application for fenofibrate from Cipla USA Inc., authorizing an updated generic fenofibrate product.
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental ANDA for fenofibrate from Glenmark Pharmaceuticals Inc., USA, authorizing a generic fenofibrate product.
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)
FDA approved a supplemental application for fenofibrate from Bostal LLC, indicating approved changes to the product's labeling/status.
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' supplemental application for fenofibrate, resulting in an approved modification to the product's label…
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for fenofibrate from Torrent Pharmaceuticals Limited, updating the product's labeling and approved i…
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved a supplemental application for fenofibrate filed by Ajanta Pharma USA Inc., authorizing continued marketing of the product unde…
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FDA approval · 2019-05-13FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for fenofibrate from ANI Pharmaceuticals, Inc.
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FDA approval · 2019-05-10FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for the generic amlodipine besylate and atorvastatin calcium combination (amlodipine and atorvastati…
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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 approval · 2019-05-06FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)
FDA approved an original application for Colesevelam hydrochloride (generic) from Ascend Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2019-05-06Clinical Trial Update: Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation [Phase 4]
Phase 4 exploratory trial assessing omega-3-acid ethyl esters (TAK-085) on vascular endothelial function in hyperlipidemia; results posted a…
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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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CLINICAL_TRIALS trial_result · 2019-04-26Clinical Trial Update: Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab [Phase 4]
Phase 4 trial update evaluating changes in atherosclerotic plaque characteristics using DCE-MRI with alirocumab.
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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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CLINICAL_TRIALS trial_result · 2019-04-23Clinical Trial Update: Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a)) [Phase 3]
Phase 3 trial evaluating PCSK9 inhibition on arterial wall inflammation in patients with elevated Lp(a); study completed with results posted…
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FDA approval · 2019-04-16FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' supplemental application for the generic fixed-dose combination ezetimibe and simvastatin.
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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 · 2019-04-10FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc. This action const…
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FDA approval · 2019-04-09FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Umedica Laboratories USA Inc.)
FDA approved a generic rosuvastatin calcium product from Umedica Laboratories USA Inc. under an Original Application (ANDA).
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CLINICAL_TRIALS trial_result · 2019-04-05Clinical Trial Update: A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol [Phase 1]
Phase 1 trial of LY3015014 in healthy participants with elevated LDL cholesterol has completed with results posted.
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FDA approval · 2019-04-04FDA Approved: PITAVASTATIN CALCIUM — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved the generic pitavastatin calcium product submitted under an Original Application by Mylan Pharmaceuticals Inc.