Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2024-01-23Clinical Trial Update: Anti-inflammatory Effects of Simvastatin [Phase 4]
Phase 4 trial evaluating anti-inflammatory effects of simvastatin was terminated, with results posted in 2024.
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FDA approval · 2024-01-05FDA Approved: ROSUVASTATIN — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for rosuvastatin from Accord Healthcare Inc. (ANDA 206434).
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FDA approval · 2024-01-05FDA Approved: ATORVASTATIN CALCIUM — Original Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's generic atorvastatin calcium under an original ANDA.
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FDA approval · 2023-12-13FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)
The FDA approved a supplemental application for Nexlizet, the fixed-dose combination of bempedoic acid and ezetimibe from Esperion Therapeut…
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CLINICAL_TRIALS trial_result · 2023-12-11Clinical Trial Update: Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction [Phase 3]
Phase 3 trial update for LIB003 evaluating long-term efficacy and safety in patients with cardiovascular risk or high cholesterol requiring …
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CLINICAL_TRIALS trial_result · 2023-12-06Clinical Trial Update: A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008) [Phase 2]
Phase 2 trial evaluating the efficacy and safety of Enclitide Chloride (MK-0616) as an oral PCSK9 inhibitor in adults with hypercholesterole…
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CLINICAL_TRIALS trial_result · 2023-11-29Clinical Trial Update: K-924 Phase III Long Term Study [Phase 3]
Phase 3 long-term study completed for K-924 in hypercholesterolemia.
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CLINICAL_TRIALS trial_result · 2023-11-29Clinical Trial Update: K-924 Phase III Confirmatory Study [Phase 3]
A Phase III confirmatory study of K-924 in hypercholesterolemia has completed.
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FDA approval · 2023-11-22FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, bringing a rosuvasta…
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CLINICAL_TRIALS trial_result · 2023-11-18Clinical Trial Update: Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia [Phase 2]
Phase 2 multiple ascending dose study of IBI306 (a PCSK-9 inhibitor) in Chinese patients with hypercholesterolemia has completed.
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CLINICAL_TRIALS trial_result · 2023-11-09Clinical Trial Update: Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin [Phase 3]
Phase 3 trial update evaluating efficacy and safety of valsartan alone and in combination with simvastatin for hypertension and hypercholest…
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FDA approval · 2023-10-30FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Inc, confirming approval of the generic formula…
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Ohm Laboratories Inc.)
FDA supplemental approval of a generic ezetimibe product by Ohm Laboratories Inc.
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for EZETIMIBE filed by Quallent Pharmaceuticals Health LLC, approving a change to the marketed EZETI…
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for EZETIMIBE from Aurobindo Pharma Limited.
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (ScieGen Pharmaceuticals Inc)
The FDA approved a supplemental application for ezetimibe by ScieGen Pharmaceuticals Inc.
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FDA approval · 2023-10-16FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)
FDA approved the original application for atorvastatin calcium from Cadila Pharmaceuticals Limited. This generic statin is used to treat hyp…
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CLINICAL_TRIALS research · 2023-10-04Clinical Trial Update: Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) [Phase 4]
A Phase 4 trial update assessing pitavastatin and atorvastatin in patients with acute coronary syndrome in Japan.
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FDA approval · 2023-09-20FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)
FDA approved a supplemental application for Nexlizet (bempedoic acid and ezetimibe) submitted by Esperion Therapeutics, Inc.
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FDA approval · 2023-08-22FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, authorizing a generi…
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FDA approval · 2023-08-09FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
FDA approved a Supplemental Application for ZOCOR (simvastatin) submitted by Organon LLC.
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FDA label_change · 2023-08-04FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) from Sun Pharmaceutical Industries.
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CLINICAL_TRIALS trial_result · 2023-08-01Clinical Trial Update: Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A [Phase 3]
A Phase 3 clinical trial evaluating the efficacy and safety of DW1125 and DW1125A for hypercholesterolemia and dyslipidemia has been complet…
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FDA approval · 2023-07-31FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.
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FDA approval · 2023-07-26FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for Colesevelam hydrochloride (ANDA 209946) submitted by Cranbury Pharmaceuticals, LLC.