Hyperlipidemia

• FDA approval · 2024-11-04
  FDA Approved: PITAVASTATIN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for pitavastatin calcium under ANDA205955. The approval pertains to the generic pitavastatin product…

• FDA approval · 2024-10-31
  FDA Approved: CHOLESTYRAMINE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves the original ANDA for cholestyramine from Macleods Pharmaceuticals Limited, a bile acid sequestrant used to reduce elevated tot…

• FDA approval · 2024-10-16
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for rosuvastatin calcium from Rising Pharma Holdings, Inc., granting approval for a generic rosu…

• FDA approval · 2024-10-15
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)

  FDA approved a supplemental application for rosuvastatin calcium from Glenmark Pharmaceuticals, confirming regulatory approval of this gener…

• FDA approval · 2024-10-11
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Colesevelam hydrochloride from Amneal Pharmaceuticals of New York LLC.

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• FDA approval · 2024-09-23
  FDA Approved: EZETIMIBE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for ezetimibe submitted by Sandoz Inc, updating the approved ezetimibe product.

• FDA approval · 2024-08-22
  FDA Approved: FENOFIBRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fenofibrate submitted by Aurobindo Pharma Limited, relating to a generic fenofibrate product.

• FDA approval · 2024-08-20
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  FDA approves a supplemental application for Repatha (evolocumab) from Amgen USA Inc., authorizing changes related to its labeling/indication…

• FDA approval · 2024-08-20
  FDA Approved: PITAVASTATIN — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for pitavastatin (generic), authorizing its manufacture and sale as a statin …

• FDA approval · 2024-08-16
  FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved the original application for colestipol hydrochloride from Edenbridge Pharmaceuticals LLC, a generic product. The drug is used …

• FDA approval · 2024-08-15
  FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approves Ascend Laboratories, LLC's supplemental application for ezetimibe.

• FDA approval · 2024-07-30
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate.

• FDA approval · 2024-07-26
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for atorvastatin calcium from Micro Labs Limited, updating the approval status of this generic stati…

• FDA approval · 2024-07-22
  FDA Approved: PITAVASTATIN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith's supplemental application for pitavastatin calcium (pitavastatin) under ANDA205955. This action authorizes the ma…

• FDA approval · 2024-07-15
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for a generic ezetimibe and simvastatin combination product (EZETIMIBE AND SIMVASTATIN) from Ascend …

• FDA approval · 2024-07-11
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Fluvastatin Sodium (generic) from Lannett Company, Inc., confirming regulatory approval for this…

• FDA approval · 2024-07-11
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for atorvastatin calcium from Aurobindo Pharma Limited, confirming approval of a generic atorvastati…

• FDA approval · 2024-07-11
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for atorvastatin calcium from NorthStar RxLLC, resulting in the approval of a generic atorvastatin c…

• FDA approval · 2024-07-10
  FDA Approved: EZETIMIBE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for ezetimibe (ANDA 210859). This is a routine supplemental approval for a gen…

• FDA approval · 2024-07-10
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental ANDA for atorvastatin calcium, enabling Zydus Lifesciences Limited to market a generic atorvastatin calcium prod…

• FDA approval · 2024-07-10
  FDA Approved: EZETIMIBE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ezetimibe submitted by Marlex Pharmaceuticals, Inc., granting an update to the approved gene…

• FDA approval · 2024-07-10
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic Ezetimibe and Simvastatin combination from Aurobindo Pharma Limited.

• FDA approval · 2024-06-17
  FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for ezetimibe from Ascend Laboratories, LLC.

• FDA approval · 2024-06-14
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for atorvastatin calcium from NorthStar RxLLC, authorizing a generic version of atorvastatin.

• FDA approval · 2024-06-11
  FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for pitavastatin from Aurobindo Pharma Limited.