Hypertriglyceridemia

• 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.

• FDA approval · 2016-11-29
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for fenofibrate, indicating an approved labeling update or new indication under…

• FDA approval · 2016-11-09
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for fenofibrate filed by Lupin Pharmaceuticals, Inc. under NDA 021695. The approval updates the feno…

• FDA approval · 2016-10-03
  FDA Approved: GEMFIBROZIL — Supplemental Application (NorthStar Rx LLC)

  FDA approves a supplemental application for Gemfibrozil from NorthStar Rx LLC under an approved ANDA.

• FDA approval · 2016-10-03
  FDA Approved: GEMFIBROZIL — Supplemental Application (Chartwell RX, LLC)

  This document indicates FDA approval of a supplemental ANDA for Gemfibrozil from Chartwell RX, LLC.

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• FDA approval · 2016-09-07
  FDA Approved: FENOFIBRIC ACID — Original Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York LLC's fenofibric acid under an original ANDA for treatment of lipid disorders including …

• FDA approval · 2016-07-12
  FDA Approved: FENOFIBRATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' fenofibrate generic as an Original Application for the treatment of lipid disorders. The approval cover…

• FDA approval · 2016-06-23
  FDA Approved: FENOFIBRATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original generic application for fenofibrate from Mylan Pharmaceuticals Inc., enabling the marketing of a fenofibrate produ…

• FDA approval · 2016-06-17
  FDA Approved: GEMFIBROZIL — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals Limited's original ANDA for gemfibrozil, authorizing a generic version of the lipid-lowering drug.

• FDA approval · 2016-05-05
  FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application (ANDA) for Fenofibrate manufactured by Aurobindo Pharma Limited, authorizing its generic fenofibrate p…

• FDA approval · 2016-04-06
  FDA Approved: LOPID — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Lopid (gemfibrozil) submitted by Parke-Davis Div of Pfizer Inc, resulting in an approved modific…

• FDA approval · 2016-02-19
  FDA Approved: GEMFIBROZIL — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Gemfibrozil filed by Chartwell RX, LLC under an existing ANDA, indicating regulatory approval re…

• FDA approval · 2016-01-21
  FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for gemfibrozil from Exelan Pharmaceuticals, Inc. (ANDA 077836).

• 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.

• FDA approval · 2015-11-27
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's original ANDA for Omega-3-acid ethyl esters (ANDA 204940). This provides a new generic option for the treatment of hyp…

• FDA approval · 2015-11-18
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Fenofibric Acid submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2015-09-16
  FDA Approved: GEMFIBROZIL — Original Application (NorthStar Rx LLC)

  FDA approved an original ANDA for a generic gemfibrozil product manufactured by NorthStar Rx LLC.

• FDA approval · 2015-09-15
  FDA Approved: GEMFIBROZIL — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Gemfibrozil under Northstar RxLLC's ANDA, authorizing changes to the approved product.

• FDA approval · 2015-08-17
  FDA Approved: FENOFIBRATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin's original application for fenofibrate (generic fenofibrate), expanding access to a lipid-lowering option.

• FDA approval · 2015-04-17
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC, resulting in a change to its ap…

• FDA approval · 2015-03-09
  FDA Approved: LOVAZA — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for LOVAZA (omega-3-acid ethyl esters) submitted by Waylis Therapeutics LLC.

• FDA approval · 2014-11-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for fenofibrate, confirming approval of a generic fenofibrate product.

• FDA approval · 2014-10-31
  FDA Approved: FENOFIBRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic fenofibrate under an Original Application.

• FDA approval · 2014-08-14
  FDA Approved: VASCEPA — Supplemental Application (Amarin Pharma Inc.)

  The FDA approved a supplemental application for Vascepa (icosapent ethyl) submitted by Amarin Pharma Inc., resulting in a labeling update re…

• FDA approval · 2014-06-25
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (KD Pharma USA, Inc.)

  FDA approved a supplemental application for Omega-3-acid ethyl esters (KD Pharma USA, Inc.), updating regulatory approval for this existing …