Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2025-11-21FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)
FDA approved a supplemental application for NEXLIZET (bempedoic acid and ezetimibe) to update/expand its labeling.
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FDA label_change · 2025-10-09FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
FDA approved a supplemental application for PRALUENT (alirocumab) submitted by Regeneron, resulting in changes to the product labeling.
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FDA label_change · 2025-03-03FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc., under the ANDA process, likely affecting labeling.
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FDA label_change · 2025-02-12FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) to support the sprinkle dosage-form labeling. This action expand…
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FDA label_change · 2023-08-04FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) from Sun Pharmaceutical Industries.
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FDA label_change · 2023-07-27FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Crestor (rosuvastatin) from AstraZeneca, resulting in a labeling change to reflect new or re…
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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 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 label_change · 2021-11-16FDA Approved: FENOFIBRATE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for fenofibrate from Apotex Corp., resulting in a label change for the generic product.
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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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FDA label_change · 2020-06-05FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA supplemental application for Fluvastatin submitted by Teva Pharmaceuticals USA, Inc. related to labeling changes.
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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 label_change · 2019-11-06FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for the amlodipine/atorvastatin combination by Mylan Pharmaceuticals, resulting in labeling changes …
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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 label_change · 2019-04-26FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
FDA approved a supplemental application for PRALUENT (alirocumab) from Regeneron, updating the product labeling to reflect new information.
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FDA label_change · 2019-03-27FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) by Sun Pharmaceutical Industries, Inc., related to this rosu…
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FDA label_change · 2018-05-18FDA Approved: FENOFIBRATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for fenofibrate from Glenmark Pharmaceuticals Inc., USA, resulting in changes to the drug’s labe…
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FDA label_change · 2017-08-04FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)
FDA is reviewing a supplemental application for LESCOL XL (fluvastatin sodium) from Sandoz Inc., likely involving changes to the product lab…
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FDA label_change · 2017-07-27FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
The FDA approved a supplemental application for PRALUENT (alirocumab) from Regeneron Pharmaceuticals to update the drug's labeling.
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FDA label_change · 2015-11-05FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) submitted by Sandoz Inc, resulting in labeling changes.
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FDA label_change · 2014-05-22FDA Approved: COLESTID — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental labeling application for COLESTID (colestipol hydrochloride) submitted by Pharmacia & Upjohn Company LLC to …
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FDA label_change · 2013-01-18FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for LIPOFEN (fenofibrate) submitted by ANI Pharmaceuticals, Inc., resulting in changes to the drug's…
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FDA label_change · 2012-04-26FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.
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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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FDA label_change · 2008-11-18FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for simvastatin by Lupin Pharmaceuticals, likely involving labeling changes. This represents a suppl…