Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-02-16FDA Approved: ICOSAPENT ETHYL — Original Application (Northstar Rx LLC)
FDA approved the original application for icospent ethyl (ICOSAPENT ETHYL) from Northstar Rx LLC, a generic version of the prescription ther…
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FDA approval · 2024-02-14FDA Approved: COLESEVELAM — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for COLESEVELAM submitted by Zydus Lifesciences Limited under ANDA207765.
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CLINICAL_TRIALS trial_result · 2024-02-14Clinical Trial Update: AlmegaPL CV Health Open Label Study [Phase 4]
Open-label Phase 4 trial of AlmegaPL for cardiovascular health completed; study focused on cholesterol and triglycerides management.
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FDA approval · 2024-02-08FDA 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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FDA approval · 2024-02-08FDA Approved: FENOFIBRIC ACID — Original Application (Macleods Pharmaceuticals Limited)
FDA approved an original application for fenofibric acid (generic) manufactured by Macleods Pharmaceuticals Limited.
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FDA approval · 2024-02-02FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)
FDA approved a supplemental application for Rosuvastatin Calcium submitted by Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2024-02-02FDA Approved: EZETIMIBE — Supplemental Application (Marlex Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ezetimibe submitted by Marlex Pharmaceuticals, Inc. The action updates the approval status f…
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FDA approval · 2024-02-01FDA Approved: GEMFIBROZIL — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for gemfibrozil by Chartwell RX, LLC.
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FDA approval · 2024-01-31FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approves a supplemental application for simvastatin from NorthStar Rx LLC (ANDA).
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FDA approval · 2024-01-31FDA Approved: FENOFIBRATE — Original Application (Chartwell RX, LLC.)
FDA approved fenofibrate (generic) under Original Application ANDA211407 for Chartwell RX, LLC. This marks the approval of a first generic v…
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FDA approval · 2024-01-30FDA Approved: EZETIMIBE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for ezetimibe from Sandoz Inc., authorizing the continued availability of a generic ezetimibe produc…
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CLINICAL_TRIALS trial_result · 2024-01-16Clinical Trial Update: Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia. [Phase 2]
A Phase 2 trial evaluating beta-glucan added to statin therapy for hyperlipidemia has completed with results posted.
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FDA approval · 2024-01-16FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)
FDA approved Biocon Pharma's supplemental application for simvastatin (ANDA078034), approving a generic simvastatin product filing.
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CLINICAL_TRIALS trial_result · 2024-01-05Clinical Trial Update: Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes [NA]
A completed clinical trial evaluating the validity of a Shared Decision Making process survey using video vignettes; results posted in 2024.
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FDA approval · 2024-01-05FDA Approved: ROSUVASTATIN — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for rosuvastatin from Accord Healthcare Inc. (ANDA 206434).
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FDA approval · 2024-01-05FDA Approved: ATORVASTATIN CALCIUM — Original Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's generic atorvastatin calcium under an original ANDA.
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CLINICAL_TRIALS trial_result · 2023-12-11Clinical Trial Update: Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction [Phase 3]
A Phase 3 clinical trial evaluating the efficacy and safety of LIB003 in patients with cardiovascular disease and high LDL-C on statins, see…
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FDA approval · 2023-11-28FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) submitted by Sandoz Inc.
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FDA approval · 2023-11-22FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Rosuvastatin calcium from Rising Pharma Holdings, Inc., granting approval of a supplemental ANDA…
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FDA approval · 2023-11-22FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, bringing a rosuvasta…
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CLINICAL_TRIALS trial_result · 2023-11-18Clinical Trial Update: Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia [Phase 2]
A Phase 2 clinical trial comparing SLx-4090 plus statin therapy versus statin alone in reducing LDL-C in patients with hyperlipidemia has co…
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FDA approval · 2023-10-30FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Inc, confirming approval of the generic formula…
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Ohm Laboratories Inc.)
FDA supplemental approval of a generic ezetimibe product by Ohm Laboratories Inc.
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for EZETIMIBE filed by Quallent Pharmaceuticals Health LLC, approving a change to the marketed EZETI…
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for EZETIMIBE from Aurobindo Pharma Limited.