Familial Hypercholesterolemia

• CLINICAL_TRIALS research · 2024-07-19
  Clinical Trial Update: PET Imaging of Inflammation and Lipid Lowering Study [NA]

  This is a clinical trial update indicating that a PET imaging study of inflammation and lipid lowering (NCT04073797) sponsored by the Univer…

• CLINICAL_TRIALS trial_result · 2024-07-18
  Clinical Trial Update: A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia

  This completed real-world study evaluated adherence, treatment patterns, patient characteristics, and effectiveness of Inclisiran in patient…

• FDA approval · 2024-07-11
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Fluvastatin Sodium (generic) from Lannett Company, Inc., confirming regulatory approval for this…

• FDA approval · 2024-07-11
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for atorvastatin calcium from NorthStar RxLLC, resulting in the approval of a generic atorvastatin c…

• FDA approval · 2024-07-10
  FDA Approved: EZETIMIBE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for ezetimibe (ANDA 210859). This is a routine supplemental approval for a gen…

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• FDA approval · 2024-07-10
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental ANDA for atorvastatin calcium, enabling Zydus Lifesciences Limited to market a generic atorvastatin calcium prod…

• 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…

• CLINICAL_TRIALS research · 2024-06-17
  Clinical Trial Update: Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH) [EARLY_Phase 1]

  An early-phase (Phase 1) trial of YOLT-101 for familial hypercholesterolemia is currently recruiting.

• FDA approval · 2024-06-14
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for atorvastatin calcium from NorthStar RxLLC, authorizing a generic version of atorvastatin.

• CLINICAL_TRIALS trial_result · 2024-05-10
  Clinical Trial Update: Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018) [Phase 3]

  This Phase 3 study MK-0653-018 assessed ezetimibe taken with either atorvastatin or simvastatin in individuals with familial hypercholestero…

• FDA approval · 2024-04-30
  FDA Approved: PITAVASTATIN CALCIUM — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's original application for pitavastatin calcium, a generic statin, to treat hyperlipidemia by lowering choleste…

• FDA approval · 2024-04-02
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

  FDA has approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC to update labeling.

• 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 · 2024-03-20
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) by Sun Pharmaceutical Industries, expanding its approved ros…

• FDA approval · 2024-03-14
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, Inc.

• CLINICAL_TRIALS trial_result · 2024-03-06
  Clinical Trial Update: Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C [Phase 3]

  Phase 3 trial update evaluating long-term dosing of inclisiran in high cardiovascular risk patients with elevated LDL-C; study completed wit…

• 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 · 2024-01-31
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approves a supplemental application for simvastatin from NorthStar Rx LLC (ANDA).

• FDA approval · 2024-01-30
  FDA Approved: EZETIMIBE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ezetimibe from Sandoz Inc., authorizing the continued availability of a generic ezetimibe produc…

• CLINICAL_TRIALS research · 2024-01-30
  Clinical Trial Update: Expression of Pro- and Anti-inflammatory Cytokines During Anti-PCSK9 in Familial Hypercholesterolemia [Phase 4]

  Phase 4 trial evaluating expression of pro- and anti-inflammatory cytokines during anti-PCSK9 therapy in familial hypercholesterolemia; comp…

• FDA approval · 2024-01-05
  FDA Approved: ROSUVASTATIN — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for rosuvastatin from Accord Healthcare Inc. (ANDA 206434).

• FDA approval · 2023-12-13
  FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)

  The FDA approved a supplemental application for Nexlizet, the fixed-dose combination of bempedoic acid and ezetimibe from Esperion Therapeut…

• CLINICAL_TRIALS trial_result · 2023-12-06
  Clinical Trial Update: A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008) [Phase 2]

  Phase 2 trial evaluating the efficacy and safety of Enclitide Chloride (MK-0616) as an oral PCSK9 inhibitor in adults with hypercholesterole…

• FDA approval · 2023-11-28
  FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)

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

• FDA approval · 2023-11-22
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Rosuvastatin calcium from Rising Pharma Holdings, Inc., granting approval of a supplemental ANDA…