Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2018-12-31FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin from NorthStar Rx LLC, updating the approved generic product's labeling/manufacturin…
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FDA approval · 2018-12-21FDA Approved: ATORVASTATIN CALCIUM — Original Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' atorvastatin calcium as an original generic application, authorizing a new generic version of atorvast…
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FDA approval · 2018-12-18FDA Approved: EZALLOR SPRINKLE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved EZALLOR SPRINKLE (rosuvastatin) under Sun Pharmaceutical Industries, Inc.'s Original Application, introducing a sprinkle-form r…
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FDA approval · 2018-11-20FDA Approved: ATORVASTATIN CALCIUM — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for atorvastatin calcium from Zydus Lifesciences Limited, granting generic approval for lowering chole…
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FDA approval · 2018-10-26FDA Approved: EZETIMIBE — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s original ANDA for a generic ezetimibe product, authorizing its marketing as a cholesterol-lowering tre…
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FDA approval · 2018-07-02FDA Approved: CHOLESTYRAMINE — Original Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved the original application for cholestyramine from Zydus Pharmaceuticals (USA) Inc., establishing a generic version of the bile a…
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FDA approval · 2018-05-16FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a generic version of Colesevelam hydrochloride from Amneal Pharmaceuticals of New York LLC for lowering elevated LDL cholestero…
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FDA approval · 2018-04-13FDA Approved: PRAVASTATIN SODIUM — Original Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma's pravastatin sodium as an original ANDA, authorizing a generic version of pravastatin for lowering cholesterol. …
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FDA approval · 2018-03-30FDA Approved: ATORVASTATIN CALCIUM — Original Application (Accord Healthcare Inc.)
FDA approves Accord Healthcare's atorvastatin calcium as an original application (ANDA) for a generic atorvastatin calcium product.
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FDA approval · 2018-02-01FDA Approved: NIACIN — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original ANDA for NIACIN, a generic niacin product intended to treat dyslipidemia and related lipid …
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FDA approval · 2017-11-22FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Quallent Pharmaceuticals Health LLC)
FDA approved the original application for rosuvastatin calcium (generic rosuvastatin calcium) from Quallent Pharmaceuticals Health LLC. The …
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FDA approval · 2017-08-25FDA Approved: EZETIMIBE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for ezetimibe from Aurobindo Pharma Limited, enabling a generic version of the cholesterol-lowering dr…
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FDA approval · 2017-08-04FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin Pharmaceuticals' supplemental application for Lovastatin (generic statin). The approval pertains to changes under the AND…
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FDA approval · 2017-07-11FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin product).
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FDA approval · 2017-06-12FDA Approved: EZETIMIBE — Original Application (Sandoz Inc)
FDA approved Sandoz Inc's original application for ezetimibe, a generic cholesterol-lowering medication. The approval confirms marketing aut…
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FDA approval · 2017-05-25FDA Approved: COLESTID — Supplemental Application (Pharmacia & Upjohn Company LLC)
FDA approved a supplemental application for COLESTID (colestipol hydrochloride) submitted by Pharmacia & Upjohn Company LLC.
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FDA approval · 2017-03-27FDA Approved: ATORVASTATIN CALCIUM — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's atorvastatin calcium as an original-application generic product.
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FDA approval · 2017-03-21FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Ascend Laboratories, LLC)
FDA approves the original ANDA for rosuvastatin calcium from Ascend Laboratories, LLC, enabling the generic rosuvastatin calcium product to …
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FDA approval · 2017-02-03FDA Approved: PITAVASTATIN — Original Application (Upsher-Smith Laboratories, LLC)
The FDA approved an original ANDA for pitavastatin calcium from Upsher-Smith Laboratories, making a generic pitavastatin product available.
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cranbury Pharmaceuticals, LLC)
FDA approved Cranbury Pharmaceuticals' rosuvastatin calcium through an Original Application for an Abbreviated New Drug Application (ANDA), …
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's original application for rosuvastatin as a generic product. Rosuvastatin is used to treat hyperlipidemia an…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves rosuvastatin (generic) under an Original Application by Camber Pharmaceuticals, adding a generic statin option for lowering cho…
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FDA approval · 2016-07-19FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Glenmark Pharmaceutials Inc., USA)
FDA approves rosuvastatin calcium as an original generic application from Glenmark Pharmaceuticals Inc., USA.
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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.