Atherosclerotic Cardiovascular Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-02-16FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for pravastatin sodium (generic pravastatin) under ANDA 076056.
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FDA approval · 2021-02-11FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for a generic Pravastatin Sodium product from Aurobindo Pharma Limited under an ANDA.
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FDA approval · 2021-02-01FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin). This represents an approved suppleme…
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FDA approval · 2021-01-15FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) manufactured by Mylan Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2020-12-22Clinical Trial Update: Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE) [Phase 3]
Phase 3 long-term safety and efficacy update of bempedoic acid (CLEAR Harmony OLE) completed; results posted in 2020.
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FDA approval · 2020-12-17FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original-application generic fixed-dose combination of ezetimibe and simvastatin.
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FDA approval · 2020-12-15FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium, manufactured by …
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CLINICAL_TRIALS trial_result · 2020-12-14Clinical Trial Update: Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM [Phase 4]
A Phase 4 trial comparing rosuvastatin/ezetimibe combination vs rosuvastatin alone in patients with ASCVD and type 2 diabetes mellitus has c…
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CLINICAL_TRIALS trial_result · 2020-12-14Clinical Trial Update: High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes [Phase 4]
Phase 4 clinical trial comparing high-intensity rosuvastatin versus moderate-intensity rosuvastatin/ezetimibe in patients with high ASCVD ri…
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FDA approval · 2020-10-13FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for ATORVASTATIN CALCIUM from Dr. Reddy's Laboratories Limited, granting approval for a generic ator…
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CLINICAL_TRIALS trial_result · 2020-10-05Clinical Trial Update: Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol [Phase 3]
Phase 3 trial update for inclisiran in participants with atherosclerotic cardiovascular disease and elevated LDL cholesterol has completed w…
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FDA approval · 2020-09-25FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for EZALLOR SPRINKLE (rosuvastatin), adding a sprinkle formulation to the rosuvas…
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FDA approval · 2020-09-25FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.
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FDA approval · 2020-09-25FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Fluvastatin (generic) under the ANDA.
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FDA approval · 2020-09-25FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)
FDA approved a supplemental application for Lovastatin (Carlsbad Technology, Inc.) to modify an existing ANDA product.
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FDA approval · 2020-09-25FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Fluvastatin Sodium (generic) filed by Mylan Pharmaceuticals Inc., enabling continued marketi…
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FDA approval · 2020-09-15FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for fluvastatin sodium submitted by Mylan Pharmaceuticals, updating the approved ANDA product.
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CLINICAL_TRIALS trial_result · 2020-08-21Clinical Trial Update: Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol [Phase 3]
Phase 3 trial update for inclisiran in subjects with atherosclerotic cardiovascular disease or risk-equivalents and elevated LDL cholesterol…
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FDA approval · 2020-08-19FDA Approved: ATORVASTATIN CALCIUM — Original Application (NIVAGEN PHARMACEUTICALS, INC.)
FDA approves an original new application for atorvastatin calcium from NIVAGEN Pharmaceuticals, a generic version of atorvastatin indicated …
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FDA approval · 2020-06-24FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)
FDA granted a supplemental approval for a generic pitavastatin product from Aurobindo Pharma Limited.
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FDA approval · 2020-06-15FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for simvastatin from Micro Labs Limited.
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FDA label_change · 2020-06-05FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA supplemental application for Fluvastatin submitted by Teva Pharmaceuticals USA, Inc. related to labeling changes.
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FDA approval · 2020-05-21FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a Supplemental Application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP, updating the drug's labe…
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FDA approval · 2020-05-05FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Simvastatin from NorthStar Rx LLC, approving the continued marketing of this generic statin.
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CLINICAL_TRIALS trial_result · 2020-04-27Clinical Trial Update: Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk [Phase 3]
Phase 3 trial update assessing long-term efficacy of bempedoic acid in patients with hypercholesterolemia at high cardiovascular risk; resul…