Hypertriglyceridemia

• FDA approval · 2023-07-19
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Fenofibric Acid by Micro Labs Limited.

• FDA approval · 2023-06-21
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Leading Pharma, LLC)

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

• FDA approval · 2023-03-27
  FDA Approved: FENOFIBRATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' Fenofibrate supplemental application.

• FDA approval · 2023-03-27
  FDA Approved: FENOFIBRATE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved a supplemental application for fenofibrate from Westminster Pharmaceuticals, LLC, authorizing changes to the generic produc…

• FDA approval · 2023-03-24
  FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fenofibrate submitted by Mylan Pharmaceuticals Inc., for a generic fenofibrate product.

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• FDA approval · 2023-03-08
  FDA Approved: ICOSAPENT ETHYL — Original Application (Dr. Reddy's Laboratories, Inc.)

  FDA approved Dr. Reddy's Laboratories' generic icosapent ethyl through an original ANDA (ANDA 209499).

• FDA approval · 2023-02-02
  FDA Approved: NIACIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for NIACIN (niacin) from Sun Pharmaceutical Industries, Inc. under ANDA200484.

• FDA approval · 2022-09-27
  FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application (ANDA) for Fenofibrate from Aurobindo Pharma Limited.

• FDA approval · 2022-08-17
  FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for gemfibrozil by Exelan Pharmaceuticals, Inc., under an ANDA supplement.

• FDA approval · 2022-07-08
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approved the supplemental application for atorvastatin calcium from NIVAGEN Pharmaceuticals, Inc., authorizing the generic product.

• FDA approval · 2022-05-25
  FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals’ supplemental application for fenofibrate, authorizing the marketing of a generic fenofibrate product.

• FDA approval · 2022-04-05
  FDA Approved: FENOFIBRATE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals' supplemental application for fenofibrate, enabling a generic fenofibrate product.

• FDA approval · 2022-04-05
  FDA Approved: FENOFIBRATE — Supplemental Application (AvKARE)

  FDA approved a supplemental application for fenofibrate from AvKARE, granting approval for a change under the ANDA for this generic product.…

• FDA approval · 2022-01-04
  FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fenofibrate from Mylan Pharmaceuticals, updating an approved generic product.

• FDA approval · 2021-12-10
  FDA Approved: GEMFIBROZIL — Supplemental Application (Cadila Pharmaceuticals Limited)

  The FDA approved a supplemental application from Cadila Pharmaceuticals Limited for Gemfibrozil, finalizing approval of a generic version un…

• FDA approval · 2021-12-10
  FDA Approved: GEMFIBROZIL — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Gemfibrozil from Zydus Lifesciences Limited. This approval updates the existing ANDA for Gem…

• FDA approval · 2021-11-29
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved the supplemental application for Fenofibric Acid submitted by Lupin Pharmaceuticals, Inc. This action approves a supplemental s…

• FDA approval · 2021-11-15
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Original Application (Lifestar Pharma LLC)

  FDA approved the original application for Omega-3-acid ethyl esters by Lifestar Pharma LLC.

• FDA approval · 2021-09-20
  FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for generic fenofibrate by Aurobindo Pharma Limited.

• FDA approval · 2021-06-30
  FDA Approved: ICOSAPENT ETHYL — Original Application (Apotex Corp)

  FDA approved Apotex Corp's original ANDA for a generic icospent ethyl product. The approval covers icosapent ethyl for the treatment of adul…

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Fenofibrate from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2021-06-03
  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 · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., updating the approved generic product.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.,)

  FDA approved a supplemental application for Fenofibrate submitted by Cipla USA Inc.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for fenofibrate by Glenmark Pharmaceuticals Inc., USA under ANDA205566, resulting in updated labelin…