Familial Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-08-19FDA Approved: ATORVASTATIN CALCIUM — Original Application (NIVAGEN PHARMACEUTICALS, INC.)
FDA approves an original new application for atorvastatin calcium from NIVAGEN Pharmaceuticals, a generic version of atorvastatin indicated …
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FDA label_change · 2020-07-29FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Welchol (colesevelam hydrochloride) to update the labeling and potentially expand its approved u…
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CLINICAL_TRIALS trial_result · 2020-07-15Clinical Trial Update: Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders [Phase 3]
Phase 3 trial assessing PCSK9 inhibition in paediatric patients with genetic LDL disorders has completed; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-07-02Clinical Trial Update: A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia [Phase 2]
Phase 2 clinical trial assessing safety, tolerability, and efficacy of SHR-1209 in patients with familial hypercholesterolemia.
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FDA approval · 2020-05-21FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a Supplemental Application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP, updating the drug's labe…
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FDA label_change · 2020-04-17FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin), updating the product label as part of a supplemental submission…
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FDA approval · 2020-04-07FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for rosuvastatin from Camber Pharmaceuticals, a generic rosuvastatin product under an ANDA.
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FDA approval · 2020-03-12FDA Approved: ROSUVASTATIN — Supplemental Application (Accord Healthcare Inc.)
FDA approved the supplemental application for rosuvastatin from Accord Healthcare Inc., extending approval for the generic rosuvastatin prod…
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FDA approval · 2020-03-10FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
FDA approved a supplemental application for Praluent (alirocumab) from Regeneron, enabling updated labeling for the drug.
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FDA approval · 2020-03-10FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cadila Pharmaceuticals Limited)
FDA approved the supplemental application for Rosuvastatin Calcium submitted by Cadila Pharmaceuticals Limited.
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Rosuvastatin Calcium from Torrent Pharmaceuticals Limited, expanding regulatory approval for thi…
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)
FDA approved Glenmark's supplemental application for rosuvastatin calcium, authorizing a generic rosuvastatin calcium product and expanding …
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)
FDA approves Westminster Pharmaceuticals' supplemental application for rosuvastatin calcium, confirming this rosuvastatin salt as an approve…
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FDA approval · 2020-01-29FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for the ezetimibe and simvastatin fixed-dose combination developed by Amneal Pharmaceuticals NY LLC.
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FDA approval · 2020-01-24FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for a generic ezetimibe and simvastatin combination product, expanding access to this lipid…
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FDA approval · 2019-10-22FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, allowing the generic product to be m…
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FDA approval · 2019-10-21FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s Supplemental Application for atorvastatin calcium, making a generic atorvastatin calcium product an approv…
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FDA approval · 2019-10-18FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for ATORVASTATIN CALCIUM submitted by Zydus Lifesciences Limited (ANDA 206536).
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FDA approval · 2019-10-16FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for atorvastatin calcium, a generic statin used to treat high cholesterol, unde…
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FDA approval · 2019-10-07FDA Approved: COLESEVELAM — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for COLESEVELAM by Zydus Lifesciences Limited, establishing a generic form of colesevelam for choleste…
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FDA label_change · 2019-10-04FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
This document records a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC, likely involving labeling…
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FDA approval · 2019-08-22FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc., authorizing a change to the generic product.
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FDA approval · 2019-08-20FDA Approved: CHOLESTYRAMINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved a supplemental application for Cholestyramine submitted by Zydus Pharmaceuticals (USA) Inc. under ANDA202901.
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FDA approval · 2019-08-07FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Rising Pharma Holdings, Inc.'s atorvastatin calcium film-coated tablets, granting regulatory app…
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CLINICAL_TRIALS trial_result · 2019-05-17Clinical Trial Update: Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) [Phase 2]
Phase 2 trial evaluating ALN-PCSSC treatment on LDL-C in patients with atherosclerotic cardiovascular disease and familial hypercholesterole…