Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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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 · 2018-11-07FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for fenofibrate from Lupin Pharmaceuticals, Inc.
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FDA approval · 2018-11-07FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for Fenofibric Acid from Amneal Pharmaceuticals of New York LLC.
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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 · 2018-10-05FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Dr.Reddys Laboratories Inc)
FDA approved a generic Colesevelam Hydrochloride (colesevelam hydrochloride) via an Original Application filed by Dr. Reddy's Laboratories I…
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FDA approval · 2018-10-05FDA Approved: COLESEVELAM HCL — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' Colesevelam HCl (generic) under ANDA209038. The drug is a bile acid sequestrant indicated to reduce LDL ch…
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FDA approval · 2018-09-12FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
The FDA granted supplemental approval for the fixed-dose combination of amlodipine besylate and atorvastatin calcium by Prasco Laboratories.
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FDA approval · 2018-09-10FDA Approved: FENOFIBRATE — Original Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s original ANDA for fenofibrate, a generic lipid-lowering medication.
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FDA approval · 2018-08-28FDA Approved: FENOFIBRATE — Original Application (Solco Healthcare US, LLC)
FDA approved the original application for fenofibrate (generic) from Solco Healthcare US, LLC, authorizing its use for certain lipid disorde…
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FDA approval · 2018-08-28FDA Approved: GEMFIBROZIL — Original Application (Zydus Lifesciences Limited)
FDA approved the original ANDA for Gemfibrozil from Zydus Lifesciences Limited, making a generic fibrate available in the United States.
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FDA approval · 2018-08-22FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
The FDA approved a supplemental application for PRALUENT (alirocumab) submitted by Regeneron Pharmaceuticals, Inc.
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FDA approval · 2018-08-17FDA Approved: FENOFIBRATE — Original Application (Leading Pharma, LLC)
FDA approved Leading Pharma, LLC's original Abbreviated New Drug Application for fenofibrate, enabling marketing of a generic fenofibrate pr…
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FDA approval · 2018-07-20FDA Approved: FENOFIBRATE — Original Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s generic fenofibrate (FENOFIBRATE) under an Original Abbreviated New Drug Application.
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FDA approval · 2018-07-16FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc.,USA)
FDA approved an Original Application for Colesevelam Hydrochloride (generic) by Glenmark Pharmaceuticals Inc., USA, marking the approval of …
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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 · 2018-06-26FDA Approved: FENOFIBRATE — Original Application (Torrent Pharmaceuticals Limited)
FDA approved Fenofibrate's original application from Torrent Pharmaceuticals Limited under ANDA210782, making a generic option available for…
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FDA approval · 2018-06-18FDA Approved: ATORVASTATIN CALCIUM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved Rising Pharma's generic atorvastatin calcium (original ANDA) for lowering cholesterol and reducing cardiovascular risk.
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FDA approval · 2018-06-07FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for atorvastatin calcium from Quallent, authorizing continued approval of this generic statin produc…
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FDA approval · 2018-05-25FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application from Prasco Laboratories for a fixed-dose combination of amlodipine and atorvastatin (amlodipine bes…
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FDA approval · 2018-05-21FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)
FDA has approved a supplemental application for ezetimibe from Ascend Laboratories, LLC, authorizing continued marketing under the ANDA.
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FDA approval · 2018-05-18FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for fenofibrate submitted by Lupin Pharmaceuticals, Inc. The notice indicates an updated approval fo…
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FDA approval · 2018-05-18FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.,)
FDA approved a supplemental application for fenofibrate filed by Cipla USA Inc. under ANDA207378.
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FDA approval · 2018-05-18FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for fenofibrate from Amneal Pharmaceuticals NY LLC, approving a generic fenofibrate product.
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FDA approval · 2018-05-18FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc.
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FDA approval · 2018-05-18FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's colesevelam hydrochloride as an original application (ANDA) for lowering LDL cholesterol in adults with primary hype…