Familial Combined Hyperlipidemia

• CLINICAL_TRIALS research · 2025-05-09
  Clinical Trial Update: Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

  A prospective German registry completed that collects data on dyslipidemia treatment indications in patients at very high cardiovascular ris…

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for fenofibrate submitted by Leading Pharma, LLC.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's supplemental application for fenofibrate (generic) under ANDA210782. The approval pertains to…

• FDA approval · 2021-05-14
  FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)

  The FDA approved a supplemental application for fenofibrate submitted by Leading Pharma, LLC.

• FDA approval · 2019-02-04
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate (NDA021695), a generic fenofibrate product.

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• FDA approval · 2017-12-19
  FDA Approved: FENOFIBRATE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' original application for fenofibrate, authorizing the marketing of a generic fenofibrate product.

• FDA approval · 2016-12-15
  FDA Approved: FENOFIBRATE — Original Application (Cipla USA Inc.)

  This FDA entry records Cipla USA Inc.'s original approval of a generic fenofibrate tablet for lipid disorders.

• CLINICAL_TRIALS research · 2016-02-10
  Clinical Trial Update: Genetic Epidemiology of Hypertriglyceridemia

  A clinical trial update from the University of Washington describing a genetic epidemiology study of hypertriglyceridemia and related lipid …

• FDA approval · 2015-12-23
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for LIPOFEN (fenofibrate) submitted by ANI Pharmaceuticals, Inc.

• CLINICAL_TRIALS withdrawal · 2015-09-10
  Clinical Trial Update: Genomic Dissection of a QTL Affecting the Lipid Profile

  A clinical trial update indicates that the study examining a quantitative trait locus affecting lipid metabolism has been withdrawn.

• CLINICAL_TRIALS trial_result · 2015-04-03
  Clinical Trial Update: Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol [Phase 4]

  A Phase 4 study comparing Welchol (colesevelam) plus TriCor (fenofibrate) to TriCor alone in patients with hypercholesterolemia and hyperlip…

• CLINICAL_TRIALS trial_result · 2014-12-11
  Clinical Trial Update: Human Lipoprotein Pathophysiology - Subproject: Genetics of Familial Combined Hyperlipidemia

  This clinical trial update reports the completion of a subproject on the genetics of familial combined hyperlipidemia, sponsored by the Univ…

• CLINICAL_TRIALS trial_result · 2014-05-05
  Clinical Trial Update: Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes [NA]

  A completed clinical trial update examining inflammatory aspects of glucose in patients with hyperlipidemia and diabetes; conditions include…

• CLINICAL_TRIALS trial_result · 2014-03-20
  Clinical Trial Update: Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia [Phase 3]

  A Phase 3 study is being conducted to evaluate the efficacy and safety of Omega-3-acids Ethylesters 90 in patients with hyperlipidemia, incl…

• FDA approval · 2012-12-19
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate, updating the product labeling and/or approvals under a sup…

• FDA approval · 2012-10-19
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC’s supplemental application for fenofibrate, authorizing the generic product's approval.

• CLINICAL_TRIALS trial_result · 2012-03-09
  Clinical Trial Update: Effects of FXR Activation on Hepatic Lipid and Glucose Metabolism [EARLY_Phase 1]

  This early-phase Phase 1 trial investigated FXR activation and its effects on hepatic lipid and glucose metabolism in participants with meta…

• CLINICAL_TRIALS trial_result · 2012-01-12
  Clinical Trial Update: Understanding the Genetic Basis of Familial Combined Hyperlipidemia in Mexican Individuals

  This completed clinical trial from UCLA investigates the genetic basis of familial combined hyperlipidemia in Mexican individuals. It provid…

• FDA approval · 2009-07-14
  FDA Approved: LOPID — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Lopid (gemfibrozil) filed by the Parke-Davis division of Pfizer Inc. The action updates the …