Familial Hypercholesterolemia

• 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 · 2025-10-09
  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…

• 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…

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• FDA label_change · 2020-07-29
  FDA 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…

• 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 · 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 · 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.