Hypertriglyceridemia

• FDA approval · 2011-05-08
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for fenofibrate (generic) from Rhodes Pharmaceuticals L.P., granting approval for an ANDA-relate…

• FDA approval · 2011-03-14
  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 · 2011-02-16
  FDA Approved: GEMFIBROZIL — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for gemfibrozil submitted by Northstar RxLLC under an ANDA.

• FDA approval · 2010-12-22
  FDA Approved: LOVAZA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for Lovaza (omega-3-acid ethyl esters) submitted by Waylis Therapeutics LLC for the treatment of hyp…

• FDA approval · 2010-09-14
  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. Fenofibric acid is a lipid-lowe…

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• FDA approval · 2010-09-13
  FDA Approved: GEMFIBROZIL — Original Application (Northstar RxLLC)

  FDA approved the original ANDA for gemfibrozil from Northstar RxLLC, providing a generic version of the lipid-lowering drug.

• FDA approval · 2010-04-30
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., authorizing changes to the approved product under …

• FDA approval · 2010-01-04
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P. under the ANDA process.

• 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 …

• FDA approval · 2009-04-20
  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 · 2008-12-15
  FDA Approved: FENOFIBRIC ACID — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved fenofibric acid under an Original Application by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2008-12-12
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc., authorizing an update to the produ…

• FDA approval · 2008-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for fenofibrate.

• FDA approval · 2008-03-26
  FDA Approved: FENOFIBRATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's generic fenofibrate (ANDA 076509) as an original application, establishing equivalence to the r…

• FDA approval · 2007-12-06
  FDA Approved: LOVAZA — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2007-11-07
  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 · 2007-06-12
  FDA Approved: LOVAZA — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2007-02-01
  FDA Approved: LOVAZA — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2006-07-27
  FDA Approved: GEMFIBROZIL — Original Application (Exelan Pharmaceuticals, Inc.)

  FDA approved the original application for a generic Gemfibrozil by Exelan Pharmaceuticals, enabling a generic version of Gemfibrozil to be m…