Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-11-29FDA Approved: NIACIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approves a supplemental ANDA for NIACIN (nicotinic acid) from Aurobindo Pharma Limited, authorizing the marketing of a generic NIACIN pr…
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FDA approval · 2022-11-23FDA Approved: ATORVASTATIN CALCIUM — Original Application (Biocon Pharma Inc.)
FDA approval of Biocon Pharma Inc.'s atorvastatin calcium as an original generic application (ANDA) aligned to the reference product labelin…
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FDA label_change · 2022-11-09FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIVALO (pitavastatin calcium) from Kowa Pharmaceuticals America, updating the drug's labelin…
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FDA approval · 2022-11-03FDA Approved: ATORVASTATIN CALCIUM — Original Application (Lepu Pharmaceutical Technology Co., Ltd.)
FDA approves the original application for atorvastatin calcium (generic) from Lepu Pharmaceutical Technology Co., Ltd. The approval adds a g…
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FDA approval · 2022-11-02FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)
FDA approved a supplemental application for Colesevelam hydrochloride (generic) from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2022-10-25FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)
FDA approved a supplemental application for atorvastatin calcium submitted by Cipla USA Inc.
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FDA approval · 2022-10-13FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental ANDA for pravastatin sodium, enabling a generic version of pravastatin.
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FDA approval · 2022-10-06FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved Mylan Pharmaceuticals' supplemental application for a generic fixed-dose combination of amlodipine and atorvastatin (amlodi…
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FDA approval · 2022-09-28FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)
FDA approved a supplemental application for Colesevelam hydrochloride (generic Colesevelam) from Glenmark Pharmaceuticals, authorizing its c…
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FDA approval · 2022-09-27FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application from Apotex Corp. for a generic amlodipine/atorvastatin combination tablet.
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FDA approval · 2022-09-27FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)
FDA approved the Original Application (ANDA) for Fenofibrate from Aurobindo Pharma Limited.
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FDA approval · 2022-08-31FDA Approved: SIMVASTATIN — Supplemental Application (XLCare Pharmaceuticals Inc.)
FDA approved a supplemental application for simvastatin from XLCare Pharmaceuticals Inc., confirming approval for the generic drug under the…
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FDA approval · 2022-08-29FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under the ANDA framework, supporting continued regulatory stat…
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FDA approval · 2022-08-29FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for simvastatin, resulting in changes to the product's labeling and/or m…
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FDA approval · 2022-08-17FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)
The FDA approved a supplemental application for gemfibrozil by Exelan Pharmaceuticals, Inc., under an ANDA supplement.
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FDA approval · 2022-07-26FDA Approved: EZETIMIBE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original ANDA for ezetimibe tablets, a generic version of Zetia used to treat hyperlipidemia. The appro…
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FDA approval · 2022-07-08FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)
FDA approved the supplemental application for atorvastatin calcium from NIVAGEN Pharmaceuticals, Inc., authorizing the generic product.
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FDA approval · 2022-06-06FDA Approved: LEQVIO — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for LEQVIO (inclisiran) submitted by Novartis Pharmaceuticals Corporation.
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FDA label_change · 2022-05-27FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.)
FDA notice of a supplemental application for fenofibrate submitted by Cipla USA Inc., likely to update labeling or usage indications.
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FDA approval · 2022-05-25FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals’ supplemental application for fenofibrate, authorizing the marketing of a generic fenofibrate product.
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CLINICAL_TRIALS trial_result · 2022-05-20Clinical Trial Update: Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
A completed clinical trial evaluating the validity and reliability of the Shared Decision Making Process Survey, sponsored by Massachusetts …
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CLINICAL_TRIALS trial_result · 2022-05-10Clinical Trial Update: Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets [Phase 4]
Phase 4 trial update evaluating the efficacy and safety of fixed-dose combination tablets containing ezetimibe/rosuvastatin and candesartan …
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CLINICAL_TRIALS trial_result · 2022-04-13Clinical Trial Update: Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia [Phase 2]
Phase 2 trial evaluating supplementation of oil palm phenolics to improve lipid profiles in individuals with minor hyperlipidaemia/hyperchol…
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FDA approval · 2022-04-05FDA Approved: FENOFIBRATE — Supplemental Application (Alembic Pharmaceuticals Inc.)
The FDA approved Alembic Pharmaceuticals' supplemental application for fenofibrate, enabling a generic fenofibrate product.
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FDA approval · 2022-04-05FDA Approved: FENOFIBRATE — Supplemental Application (AvKARE)
FDA approved a supplemental application for fenofibrate from AvKARE, granting approval for a change under the ANDA for this generic product.…