Atherosclerotic Cardiovascular Disease

• FDA approval · 2024-12-19
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

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

• FDA approval · 2024-12-17
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for atorvastatin calcium (generic) from Ascend Laboratories, LLC, for this ANDA, approving regulator…

• FDA approval · 2024-12-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for a generic rosuvastatin calcium product from Quallent Pharmaceuticals Health LLC under ANDA20…

• FDA approval · 2024-12-05
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atorvastatin calcium from Mylan Pharmaceuticals Inc., authorizing the continued marketing of the…

• FDA approval · 2024-12-04
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., enabling the generic atorvastatin …

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• FDA approval · 2024-11-27
  FDA Approved: SIMVASTATIN — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' original application for a generic simvastatin product, adding another generic option for choleste…

• FDA approval · 2024-11-20
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  The FDA approved a supplemental application for Repatha (evolocumab) submitted by Amgen USA Inc.

• 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 · 2024-11-04
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the fixed-dose combination of amlodipine and atorvastatin by Prasco Laboratories.

• 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 · 2024-10-16
  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 · 2024-08-20
  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 · 2024-07-26
  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 · 2024-07-15
  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.