Familial Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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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 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 · 2022-08-31FDA 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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CLINICAL_TRIALS trial_result · 2022-07-19Clinical Trial Update: Alirocumab and Plaque Burden In Familial Hypercholesterolaemia [Phase 4]
Phase 4 trial update on alirocumab and plaque burden in familial hypercholesterolemia has completed.
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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 approval · 2022-03-07FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC.
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CLINICAL_TRIALS trial_result · 2022-01-14Clinical Trial Update: Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia) [Phase 3]
Phase 3 trial evaluating safety, tolerability and efficacy of evolocumab in children with familial hypercholesterolemia; study completed wit…
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CLINICAL_TRIALS trial_result · 2022-01-14Clinical Trial Update: Evaluating the Efficacy of Pediatric Lipid Screening Alerts [NA]
A completed pediatric trial evaluating lipid screening alerts to improve identification or management of high cholesterol in children; resul…
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FDA approval · 2021-07-14FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Inc)
The FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as a generic tablet under an Original Application (ANDA214659), authorizing …
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FDA approval · 2021-05-17FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for atorvastatin calcium by Accord Healthcare Inc., authorizing the continued commercialization of t…
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FDA approval · 2021-05-04FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA granted supplemental approval for atorvastatin calcium from Dr. Reddy's Laboratories Limited under an ANDA.
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CLINICAL_TRIALS trial_result · 2021-04-01Clinical Trial Update: Impact of LDL-cholesterol Lowering on Platelet Activation [Phase 4]
Phase 4 trial examining the impact of LDL-cholesterol lowering on platelet activation in familial hypercholesterolemia was terminated with r…
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FDA approval · 2021-03-17FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for a generic ezetimibe and simvastatin product from Dr. Reddy's Laboratories, authorizing its marke…
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FDA approval · 2021-03-05FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare's generic pravastatin sodium, updating its regulatory status as an approved ge…
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FDA approval · 2021-02-26FDA Approved: REPATHA — Original Application (Amgen USA Inc.)
FDA approved Repatha (evolocumab) from Amgen USA Inc. in an original application to lower LDL cholesterol in adults with familial hyperchole…
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FDA approval · 2021-02-23FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for EZETIMIBE AND SIMVASTATIN by Ascend Laboratories, LLC. The approval covers changes under the…
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FDA approval · 2021-02-01FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin). This represents an approved suppleme…
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FDA approval · 2021-01-15FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) manufactured by Mylan Pharmaceuticals Inc.
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FDA approval · 2020-10-23FDA Approved: EZETIMIBE — Original Application (ScieGen Pharmaceuticals Inc)
FDA approved ScieGen Pharmaceuticals' original (ANDA) application for ezetimibe as a generic cholesterol-lowering medication.
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FDA approval · 2020-09-25FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for EZALLOR SPRINKLE (rosuvastatin), adding a sprinkle formulation to the rosuvas…
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FDA approval · 2020-09-25FDA 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 · 2020-09-15FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for fluvastatin sodium submitted by Mylan Pharmaceuticals, updating the approved ANDA product.