Atherosclerotic Cardiovascular Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-07-19FDA Approved: ROSUVASTAIN CALCIUM — Original Application (Chartwell RX, LLC)
FDA approves ROSUVASTAIN CALCIUM as an original generic (ANDA) application for rosuvastatin calcium. The approval enables marketing of this …
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FDA approval · 2016-07-19FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved an original Abbreviated New Drug Application for rosuvastatin calcium from Rising Pharma Holdings, Inc.
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CLINICAL_TRIALS research · 2016-06-16Clinical Trial Update: Telomeres and Arterial Aging
The document provides an update on a clinical trial exploring the role of telomeres in arterial aging related to atherosclerotic disease, sp…
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FDA approval · 2016-05-19FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s atorvastatin calcium tablet as an Original Application, enabling a generic atorvastatin calcium product to…
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CLINICAL_TRIALS withdrawal · 2016-05-11Clinical Trial Update: Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in PCI Patients
A clinical trial evaluating the effectiveness of statins on lipid goal attainment in patients undergoing percutaneous coronary intervention …
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FDA approval · 2016-05-05FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)
FDA approved Biocon Pharma Inc.'s supplemental application for simvastatin (ANDA 078034). This confirms an approved modification to the gene…
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FDA approval · 2016-02-24FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, authorizing the generic atorvastatin…
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CLINICAL_TRIALS trial_result · 2016-02-18Clinical Trial Update: Stress Reduction and Atherosclerotic CVD in Blacks [Phase 3]
Phase 3 trial studying stress reduction in atherosclerotic cardiovascular disease among Black participants has completed. The update notes c…
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FDA approval · 2016-01-27FDA Approved: FLUVASTATIN SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's generic fluvastatin sodium as an original ANDA, enabling its use to treat hyperlipidemia and reduce cardiovascular risk.
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CLINICAL_TRIALS withdrawal · 2015-12-10Clinical Trial Update: Proof of Mechanism Study of MLN1202 on Atherosclerotic Inflammation in Participants With Stable Atherosclerotic Cardiovascular Disease [Phase 2]
Phase 2 proof-of-mechanism study of MLN1202 in stable atherosclerotic cardiovascular disease has been withdrawn.
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CLINICAL_TRIALS trial_result · 2015-12-09Clinical Trial Update: Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [Phase 3]
Phase 3 trial update reporting the effects of ticagrelor on preventing cardiovascular events in patients with prior myocardial infarction, c…
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FDA approval · 2015-11-30FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for pravastatin sodium from Teva Pharmaceuticals USA, Inc., authorizing a generic pravastatin produc…
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CLINICAL_TRIALS research · 2015-11-17Clinical Trial Update: Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism [Phase 3]
Phase 3 clinical trial assessing how growth hormone influences intestinal triglyceride-rich lipoprotein metabolism in patients with atherosc…
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FDA approval · 2015-11-09FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for atorvastatin calcium (generic) by Mylan Pharmaceuticals, confirming an additional aspect of its …
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FDA label_change · 2015-11-05FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) submitted by Sandoz Inc, resulting in labeling changes.
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FDA approval · 2015-10-15FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.
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FDA approval · 2015-10-06FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)
The FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., granting regulatory approval f…
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FDA approval · 2015-07-24FDA Approved: PRALUENT — Original Application (Regeneron Pharmaceuticals, Inc.)
FDA approved the original application for PRALUENT (alirocumab) by Regeneron. It is indicated to lower LDL cholesterol in adults with hetero…
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EMA approval · 2015-07-24Praluent recommended for approval to lower cholesterol
The European Medicines Agency recommended approval of Praluent (alirocumab) to lower cholesterol, pursuing a new indication.
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FDA approval · 2015-07-09FDA Approved: NIACIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for NIACIN (nicotinic acid) from Sun Pharmaceutical Industries, Inc., relating to an additional appr…
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FDA approval · 2015-06-01FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP.
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EMA approval · 2015-05-22First-in-class treatment to lower cholesterol
EMA announces a first-in-class treatment to lower cholesterol, representing a novel mechanism for managing the condition.
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FDA approval · 2015-04-28FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for atorvastatin calcium (Quallent).
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FDA approval · 2015-04-15FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Pravastatin Sodium submitted by Aurobindo Pharma Limited, approving this generic statin product.
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FDA approval · 2015-04-06FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Quallent)
The FDA approved a supplemental application for atorvastatin calcium from Quallent, granting updated regulatory approval for this generic st…