Dyslipidemia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2023-02-28Clinical Trial Update: Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension [Phase 3]
Open-label Phase 3 extension evaluating cardiovascular outcomes with PCSK9 inhibition in adults at elevated risk with dyslipidemia; study co…
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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: Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries [Phase 3]
Amgen's Fourier open-label extension study in adults with clinically evident cardiovascular disease and dyslipidemia was terminated, with re…
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FDA approval · 2022-11-29FDA Approved: NIACIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approves a supplemental ANDA for NIACIN (nicotinic acid) from Aurobindo Pharma Limited, authorizing the marketing of a generic NIACIN pr…
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CLINICAL_TRIALS trial_result · 2022-11-18Clinical Trial Update: A Study of AZD8233 in Participants With Dyslipidemia [Phase 2]
Phase 2 clinical trial of AZD8233 in participants with dyslipidemia has completed with results posted.
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FDA label_change · 2022-11-09FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIVALO (pitavastatin calcium) from Kowa Pharmaceuticals America, updating the drug's labelin…
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CLINICAL_TRIALS trial_result · 2022-11-04Clinical Trial Update: Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol [Phase 1, Phase 2]
Phase 1/2 safety and pharmacokinetic study of RVX000222 in healthy subjects and individuals with low HDL cholesterol completed.
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CLINICAL_TRIALS trial_result · 2022-08-05Clinical Trial Update: Efficacy and Safety of Berlim 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia [Phase 3]
Clinical trial update for Berlim 25/10 in Type 2 Diabetes Mellitus and Dyslipidemia (Phase 3) with status currently unknown.
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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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FDA approval · 2022-04-05FDA Approved: FENOFIBRATE — Supplemental Application (Alembic Pharmaceuticals Inc.)
The FDA approved Alembic Pharmaceuticals' supplemental application for fenofibrate, enabling a generic fenofibrate product.
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FDA approval · 2022-03-03FDA Approved: NIACIN — Original Application (Macleods Pharmaceuticals Limited)
FDA approved the original application for NIACIN (nicotinic acid) from Macleods Pharmaceuticals Limited, establishing a generic version of t…
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CLINICAL_TRIALS trial_result · 2022-03-02Clinical Trial Update: Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP. [Phase 3]
Phase 3 trial evaluating the efficacy and safety of a fixed-dose combination of atorvastatin and fenofibrate versus atorvastatin alone in pa…
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CLINICAL_TRIALS withdrawal · 2022-02-18Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406) [Phase 4]
Phase 4 trial evaluating Vytorin vs standard statin therapy for dyslipidemia was withdrawn.
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FDA label_change · 2021-11-16FDA Approved: FENOFIBRATE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for fenofibrate from Apotex Corp., resulting in a label change for the generic product.
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FDA approval · 2021-09-20FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)
FDA approves the original application for generic fenofibrate by Aurobindo Pharma Limited.
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CLINICAL_TRIALS trial_result · 2021-07-28Clinical Trial Update: Clinical Trial to Evaluate the Efficacy and Safety of CKD-386 [Phase 3]
Phase 3 clinical trial evaluating CKD-386 for efficacy and safety in patients with dyslipidemia and hypertension has completed.
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FDA approval · 2021-06-03FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Fenofibrate from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2021-06-03FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., updating the approved generic product.
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FDA approval · 2021-06-03FDA Approved: FENOFIBRATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for fenofibrate by Glenmark Pharmaceuticals Inc., USA under ANDA205566, resulting in updated labelin…
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FDA approval · 2021-06-03FDA Approved: FENOFIBRATE — Supplemental Application (Ajanta Pharma USA Inc.)
The FDA approved a supplemental application for fenofibrate from Ajanta Pharma USA Inc., indicating an approved change to the generic produc…
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FDA approval · 2021-06-03FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)
FDA approved a supplemental application for fenofibrate submitted by Leading Pharma, LLC.
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FDA approval · 2021-06-03FDA Approved: FENOFIBRATE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
The FDA approved a supplemental application for fenofibrate from Dr. Reddy's Laboratories, indicating an approved change to the product unde…
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FDA approval · 2021-05-14FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)
The FDA approved a supplemental application for fenofibrate submitted by Leading Pharma, LLC.
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CLINICAL_TRIALS withdrawal · 2021-05-10Clinical Trial Update: Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia [Phase 3]
Phase 3 trial comparing NK-104-CR and Livalo IR in primary hyperlipidemia or mixed dyslipidemia has been withdrawn.
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CLINICAL_TRIALS withdrawal · 2021-05-10Clinical Trial Update: Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia [Phase 3]
Phase 3 trial NK-104-CR for primary hyperlipidemia or mixed dyslipidemia was withdrawn.