Hypertriglyceridemia
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CLINICAL_TRIALS trial_result · 2023-11-15Clinical Trial Update: Study of the Efficacy and Safety of EPA in Patients With Type-2 Diabetes [Phase 4]
Phase 4 clinical trial assessing efficacy and safety of EPA in patients with type 2 diabetes and hypertriglyceridemia.
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CLINICAL_TRIALS research · 2023-10-30Clinical Trial Update: The Effect of Omega-3 FA on Hypertriglyceridemia in Patients With T2DM(OCEAN) [Phase 4]
A Phase 4 clinical trial assessing the impact of omega-3 fatty acids on hypertriglyceridemia in patients with type 2 diabetes mellitus.
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FDA approval · 2023-09-20FDA Approved: FENOFIBRIC ACID — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for fenofibric acid from Aurobindo Pharma Limited, updating the product’s labeling as part of the su…
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FDA approval · 2023-09-07FDA Approved: FENOFIBRATE — Original Application (Creekwood Pharmaceuticals LLC)
The FDA approved Creekwood Pharmaceuticals LLC's original ANDA for a generic fenofibrate product.
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FDA approval · 2023-07-19FDA Approved: FENOFIBRIC ACID — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for Fenofibric Acid by Micro Labs Limited.
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FDA approval · 2023-06-21FDA Approved: FENOFIBRIC ACID — Supplemental Application (Leading Pharma, LLC)
FDA approved a supplemental application for fenofibric acid submitted by Leading Pharma, LLC.
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CLINICAL_TRIALS trial_result · 2023-06-01Clinical Trial Update: Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes [Phase 2]
Phase 2 clinical trial assessing efficacy and safety of epeleuton in patients with hypertriglyceridemia and Type 2 diabetes has been termina…
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CLINICAL_TRIALS trial_result · 2023-04-07Clinical Trial Update: Effects of DPP-4 Inhibition on Triglycerides [Phase 4]
Phase 4 trial evaluating the effects of DPP-4 inhibition on triglyceride levels in patients with type 2 diabetes and hypertriglyceridemia is…
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FDA approval · 2023-03-27FDA Approved: FENOFIBRATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' Fenofibrate supplemental application.
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FDA approval · 2023-03-27FDA Approved: FENOFIBRATE — Supplemental Application (Westminster Pharmaceuticals, LLC)
The FDA approved a supplemental application for fenofibrate from Westminster Pharmaceuticals, LLC, authorizing changes to the generic produc…
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FDA approval · 2023-03-24FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for fenofibrate submitted by Mylan Pharmaceuticals Inc., for a generic fenofibrate product.
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CLINICAL_TRIALS trial_result · 2023-03-15Clinical Trial Update: Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects [Phase 2]
Phase 2 open-label trial evaluating MN-001 on HDL and triglycerides in subjects with NASH/NAFLD completed with results posted.
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FDA approval · 2023-03-08FDA Approved: ICOSAPENT ETHYL — Original Application (Dr. Reddy's Laboratories, Inc.)
FDA approved Dr. Reddy's Laboratories' generic icosapent ethyl through an original ANDA (ANDA 209499).
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CLINICAL_TRIALS trial_result · 2023-02-16Clinical Trial Update: Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis [Phase 2]
Phase 2 trial update on repeat-dose evinacumab for severe hypertriglyceridemia at risk for acute pancreatitis, with completed status and pos…
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FDA approval · 2023-02-02FDA Approved: NIACIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for NIACIN (niacin) from Sun Pharmaceutical Industries, Inc. under ANDA200484.
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CLINICAL_TRIALS trial_result · 2023-01-11Clinical Trial Update: Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) [Phase 2]
Phase 2 trial of ISIS 678354 (AKCEA-APOCIII-LRx) in participants with hypertriglyceridemia and established cardiovascular disease completed …
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CLINICAL_TRIALS trial_result · 2022-11-30Clinical Trial Update: Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function [Phase 3]
Phase 3 study evaluating safety and efficacy of K-877 in adults with fasting high triglycerides and normal renal function has completed with…
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CLINICAL_TRIALS trial_result · 2022-11-01Clinical Trial Update: Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis [Phase 4]
Phase 4 trial update on insulin with standard management for hypertriglyceridemic acute pancreatitis.
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CLINICAL_TRIALS trial_result · 2022-10-28Clinical Trial Update: Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment [Phase 3]
Phase 3 trial update evaluating K-877 for severe hypertriglyceridemia with renal impairment has completed with results posted.
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FDA approval · 2022-09-27FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)
FDA approved the Original Application (ANDA) for Fenofibrate from Aurobindo Pharma Limited.
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FDA approval · 2022-08-17FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)
The FDA approved a supplemental application for gemfibrozil by Exelan Pharmaceuticals, Inc., under an ANDA supplement.
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FDA approval · 2022-07-08FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)
FDA approved the supplemental application for atorvastatin calcium from NIVAGEN Pharmaceuticals, Inc., authorizing the generic product.
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FDA label_change · 2022-05-27FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.)
FDA notice of a supplemental application for fenofibrate submitted by Cipla USA Inc., likely to update labeling or usage indications.
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FDA approval · 2022-05-25FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals’ supplemental application for fenofibrate, authorizing the marketing of a generic fenofibrate product.
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CLINICAL_TRIALS trial_result · 2022-04-25Clinical Trial Update: Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) [Phase 3]
Phase 3 trial evaluating AMR101 (ethyl icosapentate) on triglyceride levels in patients with hypertriglyceridemia on statins; study complete…