Mixed Dyslipidemia

• FDA approval · 2020-03-18
  FDA Approved: FENOFIBRATE — Original Application (Laurus Labs Limited)

  The FDA approved Laurus Labs Limited's original application for a generic fenofibrate product, granting approval for a generic version of fe…

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)

  FDA approved Glenmark's supplemental application for rosuvastatin calcium, authorizing a generic rosuvastatin calcium product and expanding …

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  The FDA approved a supplemental application for the generic fixed-dose combination ezetimibe and simvastatin by Dr. Reddy's Laboratories. Th…

• FDA approval · 2020-01-17
  FDA Approved: FENOFIBRATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's fenofibrate generic under an original ANDA (ANDA213252).

• FDA approval · 2019-11-26
  FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Gemfibrozil submitted by Exelan Pharmaceuticals, Inc., likely updating the product labeling.

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• FDA approval · 2019-10-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)

  The FDA approved a supplemental application for atorvastatin calcium from Novadoz Pharmaceuticals LLC, authorizing its continued availabilit…

• FDA approval · 2019-10-25
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's supplemental application for fenofibrate (generic fenofibrate) under ANDA209950, resulting …

• FDA approval · 2019-10-22
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, allowing the generic product to be m…

• FDA approval · 2019-10-21
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)

  The FDA approved Cipla USA Inc.'s Supplemental Application for atorvastatin calcium, making a generic atorvastatin calcium product an approv…

• FDA approval · 2019-09-23
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC (ANDA 200264), authorizing the gener…

• FDA approval · 2019-09-23
  FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for fenofibrate from Leading Pharma, LLC (ANDA).

• FDA approval · 2019-09-23
  FDA Approved: FENOFIBRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fenofibrate filed by Aurobindo Pharma Limited, approving changes to the generic fenofibrate prod…

• FDA approval · 2019-09-06
  FDA Approved: FENOFIBRATE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for fenofibrate by Dr. Reddy's Laboratories Inc., authorizing the product as a generic.

• FDA approval · 2019-08-09
  FDA Approved: FENOFIBRATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic's fenofibrate as an Original Application (ANDA). The generic fenofibrate is approved for treating lipid disorders such …

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for fenofibrate from Lupin Pharmaceuticals, Inc. under the drug’s existing approval.

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental ANDA for fenofibrate from Glenmark Pharmaceuticals Inc., USA, authorizing a generic fenofibrate product.

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for fenofibrate, resulting in an approved modification to the product's label…

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for fenofibrate filed by Ajanta Pharma USA Inc., authorizing continued marketing of the product unde…

• FDA approval · 2019-05-13
  FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for fenofibrate from ANI Pharmaceuticals, Inc.

• FDA approval · 2019-04-12
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC.

• FDA approval · 2019-04-02
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.

• FDA approval · 2019-03-28
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2019-02-11
  FDA Approved: FENOFIBRATE — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original application for a generic fenofibrate product used to treat hyperlipidemia, hypertriglyceridemia, …

• FDA approval · 2018-12-13
  FDA Approved: GEMFIBROZIL — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved a supplemental application for gemfibrozil filed by Cadila Pharmaceuticals Limited, changing the labeling of this generic lipid…

• FDA approval · 2018-11-07
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for fenofibrate from Lupin Pharmaceuticals, Inc.