Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-06-02FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for pitavastatin from Aurobindo Pharma Limited (ANDA206015).
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FDA approval · 2023-05-31FDA Approved: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA supplemental approval for a generic fixed-dose combination of amlodipine besylate and atorvastatin calcium by Dr. Reddy's Laboratories I…
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FDA approval · 2023-04-25FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium submitted by Dr. Reddy's Laboratories Limited.
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FDA approval · 2023-04-25FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Limited.
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CLINICAL_TRIALS trial_result · 2023-04-19Clinical Trial Update: The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia [Phase 3]
A Phase 3 trial assessing multiple-dose safety and efficacy of JS002 in patients with hyperlipidemia has completed.
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FDA approval · 2023-04-13FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a generic pravastatin sodium product by Aurobindo Pharma Limited, authorizing its continued …
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FDA approval · 2023-04-11FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental ANDA for Colesevelam Hydrochloride, allowing the marketing of a generic Colesevelam Hydrochloride produ…
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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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FDA approval · 2023-03-20FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Pravastatin Sodium from Aurobindo Pharma Limited, confirming continued approval of this generic …
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CLINICAL_TRIALS trial_result · 2023-03-15Clinical Trial Update: The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia [Phase 3]
Phase 3 trial evaluating the efficacy and safety of JS002 for primary hypercholesterolemia and mixed hyperlipidemia has completed.
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FDA approval · 2023-03-14FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC.
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FDA approval · 2023-03-13FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for pravastatin sodium from Accord Healthcare Inc., indicating regulatory action on this generic pro…
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FDA approval · 2023-03-10FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' original-application approval for Colestipol hydrochloride, a generic cholesterol-lowering medicine used t…
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FDA approval · 2023-03-08FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s supplemental application for atorvastatin calcium (generic atorvastatin calcium) under an ANDA.
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FDA approval · 2023-02-02FDA Approved: NIACIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for NIACIN (nicotinic acid) from Sun Pharmaceutical Industries, Inc.
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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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FDA approval · 2023-01-18FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved an original application for colesevelam hydrochloride by Amneal Pharmaceuticals of New York LLC, granting a generic version of …
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FDA approval · 2023-01-13FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Crestor (rosuvastatin) from AstraZeneca Pharmaceuticals LP.
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FDA approval · 2023-01-03FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for atorvastatin calcium from Ascend Laboratories, LLC, approving the generic atorvastatin calci…
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FDA approval · 2022-12-16FDA Approved: EZETIMIBE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for EZETIMIBE from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2022-12-16FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for the fixed-dose combination of ezetimibe and simvastatin from Ascend Laboratories, LLC.
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FDA approval · 2022-12-16FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for ezetimibe from Ascend Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2022-11-30Clinical Trial Update: The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia [Phase 1, Phase 2]
A completed Phase 1/2 trial evaluating multiple subcutaneous injections of SHR-1209 in adults with hyperlipidemia to assess safety, tolerabi…