Dyslipidemia

• FDA approval · 2017-06-16
  FDA Approved: NIACIN — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's NIACIN generic (nicotinic acid) under ANDA 203899. The approval covers a generic niacin product indicated f…

• FDA approval · 2017-05-12
  FDA Approved: FENOFIBRIC ACID — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved an original application for a generic fenofibric acid product manufactured by Alembic Pharmaceuticals Limited.

• FDA approval · 2017-04-07
  FDA Approved: FENOFIBRATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original application for Fenofibrate (generic), a lipid-lowering drug for hyperlipidemia, hypertriglyceridemia, …

• FDA approval · 2017-03-21
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Ascend Laboratories, LLC)

  FDA approves the original ANDA for rosuvastatin calcium from Ascend Laboratories, LLC, enabling the generic rosuvastatin calcium product to …

• FDA approval · 2017-02-03
  FDA Approved: PITAVASTATIN — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's original application for pitavastatin calcium, a generic statin indicated to treat hyperlipidemia by lowering cholestero…

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• 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 · 2016-07-12
  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 · 2016-01-21
  FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)

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

• FDA approval · 2015-10-15
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for simvastatin submitted by NorthStar Rx 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 · 2015-08-31
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' Supplemental NDA for fenofibrate, authorizing approved changes to this lipid-lowering medicine. This act…

• FDA approval · 2013-10-25
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC to the existing NDA.

• FDA approval · 2013-10-18
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Fenofibrate submitted by Lupin Pharmaceuticals, Inc. This indicates a change or addition to …

• FDA approval · 2013-01-28
  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 · 2012-12-07
  FDA Approved: FENOFIBRATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves Mylan's original ANDA for fenofibrate, enabling the marketing of a generic fenofibrate product.

• FDA approval · 2012-11-15
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) filed by Organon LLC.

• FDA approval · 2012-05-29
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Quallent)

  The FDA approved Quallent's Abbreviated New Drug Application for atorvastatin calcium, establishing a generic atorvastatin calcium product. …

• FDA approval · 2012-03-01
  FDA Approved: FENOFIBRATE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's original application (ANDA090859) for a generic fenofibrate product, authorizing its marketi…

• FDA approval · 2012-02-07
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

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

• FDA approval · 2011-10-06
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for ZOCOR (simvastatin) filed by Organon LLC.

• FDA approval · 2011-07-26
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.

• 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 · 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…

• 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 …