Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-10-07FDA Approved: COLESEVELAM — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for COLESEVELAM by Zydus Lifesciences Limited, establishing a generic form of colesevelam for choleste…
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FDA label_change · 2019-10-04FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
This document records a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC, likely involving labeling…
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CLINICAL_TRIALS trial_result · 2019-10-01Clinical Trial Update: The SCCS Polypill Pilot Trial [Phase 2]
Phase 2 pilot trial update for the SCCS Polypill addressing hypertension and hyperlipidemia; trial completed with results posted.
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FDA approval · 2019-09-26FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories, LLC (ANDA209222).
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FDA approval · 2019-09-23FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for fenofibrate (generic). This action grants an additional approval to the AND…
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FDA approval · 2019-09-23FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC (ANDA 200264), authorizing the gener…
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FDA approval · 2019-09-23FDA Approved: FENOFIBRATE — Supplemental Application (AvKARE)
The FDA has approved a supplemental application for AvKARE's fenofibrate product, signaling an update to the approved formulation/manufactur…
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FDA approval · 2019-09-23FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)
FDA approved a supplemental application for fenofibrate from Leading Pharma, LLC (ANDA).
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FDA approval · 2019-09-23FDA Approved: FENOFIBRATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for fenofibrate filed by Aurobindo Pharma Limited, approving changes to the generic fenofibrate prod…
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CLINICAL_TRIALS trial_result · 2019-09-20Clinical Trial Update: Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease [Phase 4]
A Phase 4 clinical trial evaluating the effects of probucol and/or cilostazol on mean intima-media thickness in patients with coronary heart…
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FDA approval · 2019-09-19FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for fenofibrate from Cipla USA Inc. The approval indicates an update or addition via a supplemental …
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FDA approval · 2019-09-13FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Bionpharma Inc.)
FDA approved a generic version of colesevelam hydrochloride (Colesevelam HCl) by Bionpharma Inc. under an original ANDA, for lipid-lowering …
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FDA approval · 2019-09-06FDA Approved: FENOFIBRATE — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved the original application for fenofibrate by Dr. Reddy's Laboratories Inc., authorizing the product as a generic.
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FDA approval · 2019-08-22FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc., authorizing a change to the generic product.
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FDA approval · 2019-08-20FDA Approved: CHOLESTYRAMINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved a supplemental application for Cholestyramine submitted by Zydus Pharmaceuticals (USA) Inc. under ANDA202901.
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FDA approval · 2019-08-15FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approves a supplemental application for fenofibrate by Mylan Pharmaceuticals, confirming continued access to this generic triglyceride-l…
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FDA approval · 2019-08-09FDA Approved: FENOFIBRATE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic's fenofibrate as an Original Application (ANDA). The generic fenofibrate is approved for treating lipid disorders such …
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FDA approval · 2019-08-07FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Rising Pharma Holdings, Inc.'s atorvastatin calcium film-coated tablets, granting regulatory app…
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FDA approval · 2019-08-07FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Simvastatin by NorthStar Rx LLC.
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CLINICAL_TRIALS trial_result · 2019-07-05Clinical Trial Update: Evaluation of the Safety and Efficacy of Long-term Use of Omega-3 Fatty Acid Ethyl Esters
A completed clinical trial evaluating the long-term safety and efficacy of omega-3 fatty acid ethyl esters in hyperlipidemia with posted res…
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FDA approval · 2019-06-27FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves Glenmark's ezetimibe and simvastatin as an original ANDA application, enabling generic availability.
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CLINICAL_TRIALS trial_result · 2019-06-11Clinical Trial Update: Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia [Phase 3]
Open-label extension study of evolocumab in adults with hyperlipidemia and mixed dyslipidemia completed; results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-06-06Clinical Trial Update: Tele-Pharmacy Intervention to Improve Treatment Adherence [NA]
A completed clinical trial investigating a tele-pharmacy intervention to improve treatment adherence in patients with hyperlipidemia and dia…
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FDA approval · 2019-05-21FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., resulting in changes to …
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FDA approval · 2019-05-21FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA has approved Cosette Pharmaceuticals' supplemental application for Welchol (colesevelam hydrochloride). This action constitutes an a…