Atherosclerotic Cardiovascular Disease

• FDA label_change · 2026-07-31
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA supplemental approval for rosuvastatin calcium from Torrent Pharmaceuticals Limited.

• FDA label_change · 2026-01-09
  FDA Approved: NEXLETOL — Supplemental Application (Esperion Therapeutics, Inc.)

  The FDA approved a supplemental application for Nexletol (bempedoic acid) from Esperion Therapeutics, Inc., expanding the drug's labeling.

• FDA label_change · 2025-11-21
  FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)

  FDA approved a supplemental application for NEXLIZET (bempedoic acid and ezetimibe) to update/expand its labeling.

• FDA label_change · 2025-10-09
  FDA 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.

• FDA label_change · 2025-02-12
  FDA 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 · 2023-08-04
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) from Sun Pharmaceutical Industries.

• FDA label_change · 2023-07-27
  FDA 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…

• FDA label_change · 2022-11-09
  FDA 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…

• FDA label_change · 2020-06-05
  FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA supplemental application for Fluvastatin submitted by Teva Pharmaceuticals USA, Inc. related to labeling changes.

• FDA label_change · 2020-04-17
  FDA 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…

• FDA label_change · 2019-10-04
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  This document records a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC, likely involving labeling…

• FDA label_change · 2019-04-26
  FDA 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.

• FDA label_change · 2019-03-27
  FDA 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…

• FDA label_change · 2017-08-04
  FDA 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…

• FDA label_change · 2017-07-27
  FDA 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.

• FDA label_change · 2015-11-05
  FDA 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.

• FDA label_change · 2012-04-26
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.

• FDA label_change · 2010-04-22
  FDA 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.

• FDA label_change · 2008-11-18
  FDA 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…

• FDA label_change · 2007-05-16
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.