Homozygous Familial Hypercholesterolemia

• EMA approval · 2026-02-26
  EMA Authorised: Evkeeza (Evinacumab) — Ultragenyx Germany GmbH

  EMA authorised Evkeeza (evinacumab) by Ultragenyx Germany GmbH for the treatment of homozygous familial hypercholesterolemia, representing E…

• FDA approval · 2026-02-25
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approved a supplemental application for Juxtapid (lomitapide) filed by Amryt Pharmaceuticals DAC.

• CLINICAL_TRIALS approval · 2025-10-28
  Clinical Trial Update: Compassionate Use of Evinacumab

  Evinacumab (brand Evkeeza) has gained marketing approval for use in pediatric homozygous familial hypercholesterolemia, as well as indicatio…

• FDA approval · 2025-09-25
  FDA Approved: EVKEEZA — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EVKEEZA (evinacumab) from Regeneron Pharmaceuticals.

• EMA approval · 2025-01-27
  EMA Authorised: Lojuxta (Lomitapide) — Chiesi Farmaceutici SpA

  The EMA authorised Lojuxta (lomitapide) for the treatment of hypercholesterolemia, with Chiesi Farmaceutici SpA as the marketing authorisati…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-07-10
  FDA Approved: EZETIMIBE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ezetimibe submitted by Marlex Pharmaceuticals, Inc., granting an update to the approved gene…

• 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 · 2024-02-21
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Zetia (ezetimibe) from Organon LLC.

• FDA approval · 2024-02-02
  FDA Approved: EZETIMIBE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ezetimibe submitted by Marlex Pharmaceuticals, Inc. The action updates the approval status f…

• FDA approval · 2023-03-21
  FDA Approved: EVKEEZA — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EVKEEZA (evinacumab) from Regeneron Pharmaceuticals, Inc. The approval updates the existing Biol…

• FDA approval · 2022-12-16
  FDA Approved: EZETIMIBE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for EZETIMIBE from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2022-07-26
  FDA Approved: EZETIMIBE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original ANDA for ezetimibe tablets, a generic version of Zetia used to treat hyperlipidemia. The appro…

• FDA approval · 2022-06-16
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  The FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC.

• FDA approval · 2022-02-01
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approves a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC.

• 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 · 2021-05-27
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) from Amryt Pharmaceuticals DAC.

• FDA approval · 2021-02-11
  FDA Approved: EVKEEZA — Original Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved the original Biologics License Application for EVKEEZA (evinacumab) from Regeneron Pharmaceuticals for the treatment of homozyg…

• 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 · 2019-12-20
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  The FDA approved a supplemental application for JUXTAPID (lomitapide) from Amryt Pharmaceuticals DAC.

• 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 · 2017-08-25
  FDA Approved: EZETIMIBE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for ezetimibe from Aurobindo Pharma Limited, enabling a generic version of the cholesterol-lowering dr…

• FDA approval · 2017-08-02
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC.

• 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 · 2017-01-19
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) from Organon LLC.

• FDA approval · 2017-01-03
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) filed by Amryt Pharmaceuticals DAC.