Hypertriglyceridemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-01-13FDA Approved: GEMFIBROZIL — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved the original ANDA for Gemfibrozil from XLCare Pharmaceuticals, granting approval for a generic version of the lipid-lowering dr…
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FDA approval · 2021-01-06FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (KD Pharma USA, Inc.)
The FDA approved a supplemental application for Omega-3-acid ethyl esters from KD Pharma USA, Inc., confirming continued approval of this ge…
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FDA approval · 2021-01-06FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for Omega-3-acid ethyl esters submitted by Chartwell RX, LLC under an ANDA.
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FDA approval · 2021-01-06FDA Approved: OMEGA-3-ACID ETHYL ESTER — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for Omega-3-acid ethyl ester (generic product by Bionpharma Inc.), supporting its continued use for …
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FDA approval · 2021-01-06FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (EPIC PHARMA, LLC)
FDA approved a supplemental application for Omega-3-acid ethyl esters (Epic Pharma, LLC) resulting in approval of a generic product via an A…
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FDA approval · 2021-01-06FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (KD Pharma USA, Inc.)
FDA approved KD Pharma USA, Inc.'s supplemental application for Omega-3-acid ethyl esters. Omega-3-acid ethyl esters are used to treat hyper…
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FDA approval · 2021-01-06FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's supplemental application for Omega-3-acid ethyl esters.
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CLINICAL_TRIALS trial_result · 2020-12-17Clinical Trial Update: Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia [Phase 1, Phase 2]
Clinical trial update assessing safety, tolerability, PK, and PD of LCQ908 in patients with severe hypertriglyceridemia across Phase 1 and P…
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FDA approval · 2020-12-10FDA Approved: LOPID — Supplemental Application (Parke-Davis Div of Pfizer Inc)
FDA approved a supplemental application for Lopid (gemfibrozil) submitted by Parke-Davis Div of Pfizer Inc.
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FDA approval · 2020-10-19FDA Approved: FENOFIBRATE — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic's generic fenofibrate under an original drug application, confirming its use for lipid disorders. Fenofibrate lowers tr…
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CLINICAL_TRIALS trial_result · 2020-10-12Clinical Trial Update: A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
Observational clinical trial assessing use of digital tools to improve adherence to Omacor therapy in patients with previous myocardial infa…
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CLINICAL_TRIALS trial_result · 2020-10-12Clinical Trial Update: A PK and PD Study of Two Formulations of Omega-3 One Gram Capsules [Phase 1, Phase 2]
Clinical trial update for two omega-3 capsule formulations; Phase 1/2 study completed in hypertriglyceridemia.
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CLINICAL_TRIALS trial_result · 2020-10-05Clinical Trial Update: Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes [Phase 2, Phase 3]
Phase 2/3 trial update for Totum-63 (Valedia) assessing effects on glucose and lipid homeostasis in prediabetes and related metabolic condit…
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FDA approval · 2020-10-02FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for omega-3-acid ethyl esters by Strides Pharma Science Limited, granting approval for a generic ver…
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FDA approval · 2020-09-04FDA Approved: LOVAZA — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for Lovaza (omega-3-acid ethyl esters) submitted by Waylis Therapeutics LLC.
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FDA approval · 2020-08-25FDA Approved: FENOFIBRATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Fenofibrate from Sun Pharmaceutical Industries, Inc.
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FDA approval · 2020-08-19FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Original Application (KD Pharma USA, Inc.)
The FDA approves the original ANDA for a generic omega-3-acid ethyl esters product manufactured by KD Pharma USA, Inc., intended to treat el…
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CLINICAL_TRIALS trial_result · 2020-08-17Clinical Trial Update: Study of Gemcabene in Adults With FPLD [Phase 1, Phase 2]
Phase 1/2 trial updates for gemcabene in adults with familial partial lipodystrophy (FPLD) and hypertriglyceridemia have been completed with…
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CLINICAL_TRIALS trial_result · 2020-08-12Clinical Trial Update: A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2) [Phase 3]
Phase 3 trial update for CaPRe in lowering very high triglycerides (TRILOGY 2) has completed.
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CLINICAL_TRIALS trial_result · 2020-06-25Clinical Trial Update: A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia [Phase 2]
Phase 2 clinical trial evaluating gemcabene for efficacy, safety, and tolerability in adults with severe hypertriglyceridemia (completed; re…
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FDA approval · 2020-06-15FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Original Application (EPIC PHARMA, LLC)
FDA approves an original ANDA for Omega-3-acid ethyl esters (a generic omega-3 fatty acid ethyl ester formulation) from Epic Pharma.
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FDA approval · 2020-06-12FDA Approved: FENOFIBRATE — Original Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's fenofibrate Original Application (ANDA213864), authorizing a generic fenofibrate product. This marks an appro…
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FDA approval · 2020-05-21FDA Approved: ICOSAPENT ETHYL — Original Application (Northstar Rx LLC)
FDA approved the original application for ICOSAPENT ETHYL (icosapent ethyl) from Northstar Rx LLC, a generic version of the brand-name produ…
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CLINICAL_TRIALS trial_result · 2020-04-09Clinical Trial Update: Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides [Phase 2]
Phase 2 trial update assessing efficacy and safety of gemcabene in patients with low HDL-C and varying triglyceride levels; study completed.
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FDA approval · 2020-04-02FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (KD Pharma USA, Inc.)
FDA approved a supplemental application for Omega-3-acid ethyl esters from KD Pharma USA, Inc., updating the labeling as part of the regulat…