Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-04-24FDA Approved: ROSUVASTATIN — Original Application (ScieGen Pharmaceuticals, Inc.)
FDA approved the original ANDA for a generic rosuvastatin product, manufactured by ScieGen Pharmaceuticals, Inc.
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FDA approval · 2019-04-16FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' supplemental application for the generic fixed-dose combination ezetimibe and simvastatin.
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FDA approval · 2019-04-12FDA 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 · 2019-04-10FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc. This action const…
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FDA approval · 2019-04-09FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Umedica Laboratories USA Inc.)
FDA approved a generic rosuvastatin calcium product from Umedica Laboratories USA Inc. under an Original Application (ANDA).
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FDA approval · 2019-04-04FDA Approved: PITAVASTATIN CALCIUM — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved the generic pitavastatin calcium product submitted under an Original Application by Mylan Pharmaceuticals Inc.
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FDA approval · 2019-04-03FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cranbury Pharmaceuticals, LLC)
FDA approved Cranbury Pharmaceuticals, LLC's supplemental application for Rosuvastatin Calcium, authorizing a generic rosuvastatin calcium p…
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FDA approval · 2019-04-02FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.
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FDA approval · 2019-03-28FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2019-03-22FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approves a supplemental application for the ezetimibe and simvastatin combination by Amneal, indicating a modification to an already-app…
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FDA approval · 2019-03-06FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)
FDA approved Biocon Pharma Inc.'s supplemental application for simvastatin (ANDA 078034). The approval concerns Biocon's generic simvastatin…
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FDA approval · 2019-03-06FDA Approved: ATORVASTATIN CALCIUM — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc. for atorvastatin calcium as a generic product under an Original Application (ANDA).
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FDA approval · 2019-03-01FDA Approved: ROSUVASTATIN — Original Application (AiPing Pharmaceutical, Inc.)
The FDA approved AiPing Pharmaceutical, Inc.'s rosuvastatin as a generic product under an original application, enabling marketing of this s…
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FDA approval · 2019-03-01FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental ANDA for fenofibrate from Amneal Pharmaceuticals NY LLC, authorizing changes to the approved generic product…
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FDA approval · 2019-02-19FDA Approved: GEMFIBROZIL — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for gemfibrozil by NorthStar Rx LLC.
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FDA approval · 2019-02-15FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)
FDA approved a supplemental application for REPATHA (evolocumab) filed by Amgen USA Inc., resulting in labeling updates.
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FDA approval · 2019-02-11FDA Approved: FENOFIBRATE — Original Application (Chartwell RX, LLC)
FDA approved Chartwell RX, LLC's original application for a generic fenofibrate product used to treat hyperlipidemia, hypertriglyceridemia, …
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FDA approval · 2019-02-08FDA Approved: ATORVASTATIN CALCIUM — Original Application (Novadoz Pharmaceuticals LLC)
FDA approves the first original application for atorvastatin calcium as a generic product from Novadoz Pharmaceuticals LLC.
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FDA approval · 2019-02-04FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate (NDA021695), a generic fenofibrate product.
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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 · 2018-12-31FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for SIMVASTATIN from Accord Healthcare, Inc., updating the approved product. This action concerns a …
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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 · 2018-12-13FDA Approved: GEMFIBROZIL — Supplemental Application (Cadila Pharmaceuticals Limited)
FDA approved a supplemental application for gemfibrozil filed by Cadila Pharmaceuticals Limited, changing the labeling of this generic lipid…
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FDA approval · 2018-12-11FDA Approved: GEMFIBROZIL — Supplemental Application (Northstar RxLLC)
FDA approved a supplemental application for gemfibrozil under an existing ANDA held by Northstar RxLLC.