Familial Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-11-25FDA Approved: SIMVASTATIN — Original Application (XLCare Pharmaceuticals Inc.)
The FDA approved the original application for SIMVASTATIN from XLCare Pharmaceuticals Inc., granting marketing authorization for a generic s…
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FDA approval · 2014-11-05FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved Accord Healthcare, Inc.'s supplemental application for simvastatin (generic statin).
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FDA approval · 2014-11-05FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for simvastatin, updating the approved generic product.
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FDA approval · 2014-11-04FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for simvastatin by Micro Labs Limited under ANDA090383, updating the regulatory status of the approv…
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FDA approval · 2014-11-04FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, confirming approval of a generic ato…
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FDA approval · 2014-11-03FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for pravastatin sodium from Dr. Reddy's Laboratories Limited.
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FDA approval · 2014-09-30FDA Approved: ZETIA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for ZETIA (ezetimibe) submitted by Organon LLC. The approval updates the product labeling to reflect…
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FDA approval · 2014-09-23FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for atorvastatin calcium by Mylan Pharmaceuticals, confirming the approval of a generic version of t…
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CLINICAL_TRIALS trial_result · 2014-08-26Clinical Trial Update: Relationships Between Plasma PCSK9 Levels, LDL-cholesterol Concentrations and Lipoprotein (a) Levels in Familial Hypercholesterolemia
This completed clinical trial examined the relationships among plasma PCSK9 levels, LDL-cholesterol concentrations, and lipoprotein(a) level…
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CLINICAL_TRIALS research · 2014-06-10Clinical Trial Update: Cardiovascular Disease in FH Heterozygous
This document provides an update on a clinical trial studying cardiovascular disease in individuals with heterozygous familial hypercholeste…
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CLINICAL_TRIALS trial_result · 2014-02-11Clinical Trial Update: A Study of the Safety and Efficacy of Patients With Familial Hypercholesterolaemia Taking Colesevelam as add-on Therapy to Their Existing Medication [Phase 4]
A Phase 4 study evaluated the safety and efficacy of adding colesevelam to patients' existing therapy for familial hypercholesterolemia and …
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CLINICAL_TRIALS trial_result · 2014-01-29Clinical Trial Update: Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia [Phase 1, Phase 2]
This trial update reports on the efficacy results from Phase 1/2 studies of a new symbiotic formulation in children with familial hyperchole…
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CLINICAL_TRIALS trial_result · 2014-01-29Clinical Trial Update: Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy [Phase 4]
A Phase 4 clinical trial evaluated LDL apheresis using H.E.L.P. therapy for familial hypercholesterolemia; results were posted after complet…
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CLINICAL_TRIALS trial_result · 2013-12-17Clinical Trial Update: Effects of Low-density Lipoprotein (LDL) Apheresis on Inflammatory and Lipid Markers
A completed trial update evaluated the effects of LDL apheresis on inflammatory and lipid markers in familial hypercholesterolemia. The tria…
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CLINICAL_TRIALS trial_result · 2013-12-04Clinical Trial Update: A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158) [Phase 1]
Phase 1 trial of extended-release niacin/laropiprant in adolescents with heterozygous familial hypercholesterolemia was terminated; results …
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CLINICAL_TRIALS trial_result · 2013-11-26Clinical Trial Update: Effect of Weight Loss on Cholesterol Metabolism in Hereditary Hypercholesterolemias and Overweight or Obesity. [NA]
A completed clinical trial evaluating how weight loss influences cholesterol metabolism in individuals with hereditary hypercholesterolemias…
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CLINICAL_TRIALS trial_result · 2013-08-27Clinical Trial Update: Flaxseed Compared With Placebo in Patients With Hypercholesterolemia [Phase 3]
Phase 3 trial comparing flaxseed with placebo in patients with familial or severe hypercholesterolemia has completed.
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CLINICAL_TRIALS trial_result · 2013-05-30Clinical Trial Update: Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Clinical trial update for Amlodipine/Atorvastatin (Caduet) under regulatory post-marketing commitments; study completed with results posted …
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FDA approval · 2013-04-18FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Pravastatin Sodium from Lupin Pharmaceuticals (ANDA 077917), formalizing approval of this generi…
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CLINICAL_TRIALS trial_result · 2013-04-05Clinical Trial Update: Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia [Phase 2]
Open-label extension study of ISIS 301012 (Mipomersen) for familial hypercholesterolemia has completed with results posted in 2013.
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FDA approval · 2013-03-26FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Fluvastatin Sodium (generic Fluvastatin) from Mylan Pharmaceuticals Inc. (ANDA 090595), enabling…
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CLINICAL_TRIALS trial_result · 2013-03-21Clinical Trial Update: Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease [Phase 3]
Phase 3 trial evaluating mipomersen (ISIS-301012) as add-on therapy in patients with heterozygous familial hypercholesterolemia and coronary…
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FDA approval · 2013-01-27FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc., finalizing the regulatory action for this generic prod…
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FDA approval · 2012-12-30FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals' supplemental application for pravastatin sodium, a generic statin, reflecting an approved update for this…
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FDA approval · 2012-11-30FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)
FDA approved Lipitor (atorvastatin calcium) under a supplemental application submitted by Viatris Specialty LLC.