Hyperlipidemia

• 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 · 2022-03-10
  FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approves a generic version of Colestipol Hydrochloride under an Original Application filed by Zydus Lifesciences Limited.

• FDA approval · 2022-03-07
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

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

• FDA approval · 2022-03-03
  FDA Approved: NIACIN — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for NIACIN (nicotinic acid) from Macleods Pharmaceuticals Limited, establishing a generic version of t…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2022-02-08
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Zhejiang Yongtai Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for Rosuvastatin Calcium from Zhejiang Yongtai Pharmaceutical Co., Ltd., resulting in an approved su…

• FDA approval · 2022-02-02
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for the ezetimibe and simvastatin combination product. This action updates the product's labeling fo…

• FDA approval · 2022-01-28
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for Colesevelam hydrochloride by Glenmark Pharmaceuticals Inc., USA, resulting in approved chang…

• 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 · 2021-12-22
  FDA Approved: LEQVIO — Original Application (Novartis Pharmaceuticals Corporation)

  FDA granted original approval for LEQVIO (inclisiran) from Novartis Pharmaceuticals Corporation. The drug lowers LDL cholesterol in adults w…

• 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 · 2021-11-30
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) from Rising Pharma Holdings, Inc., confirming approv…

• 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 · 2021-10-20
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc. to update the…

• 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 · 2021-09-15
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2021-09-14
  FDA Approved: CHOLESTYRAMINE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for cholestyramine filed by Ajanta Pharma USA Inc., indicating an update to the product's approv…

• FDA approval · 2021-08-31
  FDA Approved: SIMVASTATIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for simvastatin submitted by XLCare Pharmaceuticals Inc., approving changes under the ANDA.

• FDA approval · 2021-07-14
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Inc)

  The FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as a generic tablet under an Original Application (ANDA214659), authorizing …

• 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…