Heterozygous Familial Hypercholesterolemia

• FDA approval · 2025-04-22
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Colesevelam hydrochloride (generic) submitted by Bionpharma Inc., effectively granting approval …

• FDA approval · 2024-03-29
  FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for ezetimibe filed by Quallent Pharmaceuticals Health LLC. This confirms approval of a new or m…

• FDA approval · 2024-03-12
  FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA supplemental approval has been granted for rosuvastatin from Camber Pharmaceuticals, indicating an approved supplemental application for…

• FDA approval · 2024-03-08
  FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved Regeneron's supplemental application for PRALUENT (alirocumab), confirming expanded regulatory authorization.

• FDA approval · 2023-01-18
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved an original application for colesevelam hydrochloride by Amneal Pharmaceuticals of New York LLC, granting a generic version of …

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• FDA approval · 2021-09-15
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2020-07-29
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., indicating an approv…

• FDA approval · 2020-04-07
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's supplemental application for ROSUVASTATIN CALCIUM, a generic rosuvastatin calcium product, under approved …

• FDA approval · 2020-02-26
  FDA Approved: NEXLIZET — Original Application (Esperion Therapeutics, Inc.)

  The FDA approved Nexlizet, a fixed-dose combination of bempedoic acid and ezetimibe, for adults with primary hyperlipidemia (including heter…

• FDA approval · 2020-02-21
  FDA Approved: NEXLETOL — Original Application (Esperion Therapeutics, Inc.)

  FDA approved Nexletol (bempedoic acid) as an original application for adults with heterozygous familial hypercholesterolemia or established …

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  The FDA approved a supplemental application for the generic fixed-dose combination ezetimibe and simvastatin by Dr. Reddy's Laboratories. Th…

• FDA approval · 2018-10-26
  FDA Approved: EZETIMIBE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s original ANDA for a generic ezetimibe product, authorizing its marketing as a cholesterol-lowering tre…

• FDA approval · 2018-05-18
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's colesevelam hydrochloride as an original application (ANDA) for lowering LDL cholesterol in adults with primary hype…

• FDA approval · 2017-06-12
  FDA Approved: EZETIMIBE — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's original application for ezetimibe, a generic cholesterol-lowering medication. The approval confirms marketing aut…

• FDA approval · 2016-11-23
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals' rosuvastatin calcium as an original generic product (ANDA 207453) for lowering cholesterol.

• FDA approval · 2015-07-24
  FDA Approved: PRALUENT — Original Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved the original application for PRALUENT (alirocumab) by Regeneron. It is indicated to lower LDL cholesterol in adults with hetero…

• FDA approval · 2014-05-20
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc. The action ap…

• FDA approval · 2012-02-28
  FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) filed by Sandoz Inc.

• FDA approval · 2011-12-01
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) by Organon LLC, updating its labeling and indications.