Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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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 · 2008-06-03FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for fenofibrate.
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FDA approval · 2008-05-30FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc., indicating a…
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FDA approval · 2008-05-29FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for a fixed-dose combination of amlodipine besylate and atorvastatin calcium (amlodipine and atorvas…
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FDA approval · 2008-03-26FDA Approved: FENOFIBRATE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's generic fenofibrate (ANDA 076509) as an original application, establishing equivalence to the r…
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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 · 2008-01-18FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc.
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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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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 approval · 2007-09-20FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium from Prasco Laborator…
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FDA approval · 2007-08-27FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc.
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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.
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FDA approval · 2006-12-20FDA Approved: SIMVASTATIN — Original Application (NorthStar Rx LLC)
The FDA approved an original application for simvastatin (generic) from NorthStar Rx LLC, making a generic version of simvastatin available.
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FDA approval · 2006-11-27FDA 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 · 2006-10-24FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved an original application for Colestipol hydrochloride, a bile acid sequestrant used to treat hyperlipidemia and hypercholesterol…