Atherosclerotic Cardiovascular Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2009-04-03FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under ANDA 077691, granting approval for a change to the gener…
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FDA approval · 2009-03-27FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC.
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FDA approval · 2009-01-08FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
FDA approved a supplemental application for VYTORIN (ezetimibe/simvastatin) submitted by Organon LLC.
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FDA label_change · 2008-11-18FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for simvastatin by Lupin Pharmaceuticals, likely involving labeling changes. This represents a suppl…
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FDA approval · 2008-11-06FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for CRESTOR (rosuvastatin) from AstraZeneca Pharmaceuticals LP. The approval updates the labeling to…
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CLINICAL_TRIALS trial_result · 2008-09-18Clinical Trial Update: Coronary Artery Bypass Grafting: Factors Related to Late Events and Saphenous Graft Patency
This clinical trial update discusses factors related to late events and saphenous graft patency after coronary artery bypass grafting.
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FDA approval · 2008-06-16FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental ANDA for a generic pravastatin sodium product, authorizing marketing of the generic statin.
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FDA approval · 2008-06-13FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) from Organon LLC.
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FDA approval · 2008-06-05FDA Approved: ZETIA — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for Zetia (ezetimibe) submitted by Organon LLC to update/expand aspects of its labeling.
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FDA approval · 2008-03-14FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for Lovastatin, finalizing changes to the generic product's approval terms and …
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FDA approval · 2008-02-26FDA Approved: SIMVASTATIN — Original Application (Accord Healthcare, Inc.)
FDA approved Accord Healthcare's generic simvastatin as an original ANDA, enabling marketing of a generic statin for lipid-lowering indicati…
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FDA approval · 2008-01-15FDA Approved: PRAVASTATIN SODIUM — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for pravastatin sodium by Aurobindo Pharma Limited, confirming a generic pravastatin product. The drug…
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FDA approval · 2008-01-08FDA Approved: PRAVASTATIN SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic pravastatin sodium tablets under Original Application, enabling a generic statin to enter the ma…
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FDA approval · 2007-12-28FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for pravastatin sodium by Quallent, updating the approval status of this generic statin.
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FDA approval · 2007-12-28FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)
FDA approved a supplemental application for pravastatin sodium submitted by Cipla USA Inc., signaling an additional regulatory approval for …
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CLINICAL_TRIALS trial_result · 2007-12-14Clinical Trial Update: Olmesartan Medoxomil in Atherosclerosis [Phase 3]
Phase 3 clinical trial update for olmesartan medoxomil in essential hypertension and atherosclerotic cardiovascular disease; the study statu…
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FDA approval · 2007-11-26FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for ZOCOR (simvastatin) from Organon LLC.
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FDA approval · 2007-11-01FDA Approved: LOVASTATIN — Original Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' original ANDA for lovastatin, allowing a generic version of the statin to be marketed.
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FDA approval · 2007-10-05FDA Approved: LOVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Lovastatin submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2007-09-26FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC.
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FDA label_change · 2007-05-16FDA 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 · 2007-05-11FDA Approved: PRAVASTATIN SODIUM — Original Application (CIPLA USA INC.)
FDA approved a generic pravastatin sodium product (Pravastatin Sodium) from Cipla USA Inc. through an Original Application (ANDA). This mark…
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FDA approval · 2007-05-11FDA Approved: SIMVASTATIN — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' original ANDA for simvastatin (generic). The approval adds a generic option for lowering cholesterol in …
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FDA approval · 2007-03-16FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for pravastatin sodium submitted by Teva Pharmaceuticals USA, Inc. under ANDA 076056. The action rel…
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FDA approval · 2007-01-16FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC.