Familial Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2012-11-28FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC under ANDA077691. The approval expands the availab…
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FDA approval · 2012-11-27FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited.
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FDA approval · 2012-11-15FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for ZOCOR (simvastatin) filed by Organon LLC.
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FDA approval · 2012-09-28FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Simvastatin from Accord Healthcare, Inc., updating the approval status under the ANDA.
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FDA approval · 2012-07-20FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)
FDA approved a supplemental application for Pravastatin Sodium by Cipla USA Inc., marking an approved change to the product's approval.
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FDA approval · 2012-07-17FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as an original ANDA, enabling a generic atorvastatin calcium product.
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FDA approval · 2012-07-12FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for pravastatin sodium (Quallent), resulting in an approved change to the generic product.
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FDA approval · 2012-07-09FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for WELCHOL (colesevelam hydrochloride) from Cosette Pharmaceuticals. The approval updates labeling …
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FDA approval · 2012-06-12FDA Approved: FLUVASTATIN — Original Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's generic fluvastatin as an original application, enabling marketing of a generic statin product.
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FDA approval · 2012-05-03FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Pravastatin Sodium from Aurobindo Pharma Limited, confirming continued approval of this generic …
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CLINICAL_TRIALS trial_result · 2012-04-27Clinical Trial Update: NHLBI Type II Coronary Intervention Study [Phase 3]
This update notes that the NHLBI Type II Coronary Intervention Study, a Phase 3 clinical trial, has completed.
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CLINICAL_TRIALS research · 2012-04-13Clinical Trial Update: Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils [NA]
This is a Clinical Trial Update exploring the effects of fish oils on postprandial lipid metabolism in individuals with familial hypercholes…
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FDA approval · 2012-03-02FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC, completing the changes described in the supplemental …
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FDA approval · 2012-01-17FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)
FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., enabling the generic atorvastatin …
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FDA approval · 2012-01-11FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved Accord Healthcare, Inc.'s supplemental application for simvastatin (ANDA 078155).
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FDA approval · 2012-01-09FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for simvastatin from Lupin Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2011-11-22Clinical Trial Update: Multiple Ascending Dose Study of SPC5001 in Treatment of Healthy Subjects and Subjects With FH [Phase 1]
A Phase 1 multiple ascending-dose study of SPC5001 in healthy subjects and individuals with familial hypercholesterolemia was terminated.
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FDA approval · 2011-09-16FDA Approved: SIMVASTATIN — Original Application (Micro Labs Limited)
FDA approves Micro Labs Limited's original ANDA for simvastatin, a generic statin, enabling broader generic access in the U.S.
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FDA approval · 2011-02-22FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Accord Healthcare's generic simvastatin (SIMVASTATIN), enabling its marketing as a generic stati…
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CLINICAL_TRIALS trial_result · 2011-01-06Clinical Trial Update: Influence of Organic Anion Transporting Polypeptide1B1(OATP1B1) Genotype on Rosuvastatin PK, PD and Lipid Profiles [Phase 4]
Phase 4 trial update examining how OATP1B1 genotype influences rosuvastatin pharmacokinetics, pharmacodynamics, and lipid responses.
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FDA approval · 2010-09-18FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC under ANDA077691. This action pertains to the appr…
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FDA approval · 2010-09-08FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC. The approval indicates an approved modification to th…
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FDA label_change · 2010-04-22FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) from Organon LLC to update the product labeling.
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CLINICAL_TRIALS trial_result · 2010-01-26Clinical Trial Update: Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol [Phase 4]
Post-marketing Phase 4 trial evaluating the efficacy and safety of colesevelam in pediatric patients with familial hypercholesterolemia.
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CLINICAL_TRIALS trial_result · 2009-09-02Clinical Trial Update: Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED) [Phase 3]
A Phase 3 trial examining carotid intima-media thickness in patients with hypercholesterolemia (familial) sponsored by Merck was terminated.…