Hypercholesterolemia

• FDA approval · 2024-11-06
  FDA Approved: ROSUVASTATIN — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for rosuvastatin by Macleods Pharmaceuticals Limited, establishing a generic rosuvastatin product. Thi…

• 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 · 2024-10-15
  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.

• 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.

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• 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 · 2024-07-11
  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 (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 (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.

• FDA approval · 2024-06-03
  FDA Approved: EZETIMIBE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ezetimibe from Aurobindo Pharma Limited, confirming regulatory approval of this generic ezetimib…

• FDA approval · 2024-03-29
  FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for ezetimibe filed by Quallent Pharmaceuticals Health LLC. This confirms approval of a new or m…

• FDA approval · 2024-03-12
  FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA supplemental approval has been granted for rosuvastatin from Camber Pharmaceuticals, indicating an approved supplemental application for…

• FDA approval · 2024-02-21
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Zetia (ezetimibe) from Organon LLC.

• FDA approval · 2024-02-08
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

• FDA approval · 2024-02-02
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)

  FDA approved a supplemental application for Rosuvastatin Calcium submitted by Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2024-02-02
  FDA Approved: EZETIMIBE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ezetimibe submitted by Marlex Pharmaceuticals, Inc. The action updates the approval status f…

• FDA approval · 2024-01-31
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approves a supplemental application for simvastatin from NorthStar Rx LLC (ANDA).

• FDA approval · 2024-01-05
  FDA Approved: ROSUVASTATIN — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for rosuvastatin from Accord Healthcare Inc. (ANDA 206434).

• FDA approval · 2024-01-05
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's generic atorvastatin calcium under an original ANDA.

• FDA approval · 2023-12-13
  FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)

  The FDA approved a supplemental application for Nexlizet, the fixed-dose combination of bempedoic acid and ezetimibe from Esperion Therapeut…