Atherosclerotic Cardiovascular Disease

• 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 · 2024-05-17
  FDA Approved: GEMFIBROZIL — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Gemfibrozil submitted by Chartwell RX, LLC.

• FDA approval · 2024-04-30
  FDA Approved: EZETIMIBE — Supplemental Application (Ohm Laboratories Inc.)

  The FDA approved a supplemental application for ezetimibe from Ohm Laboratories Inc., updating the regulatory status of the product.

• FDA approval · 2024-04-30
  FDA Approved: PITAVASTATIN CALCIUM — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's original application for pitavastatin calcium, a generic statin, to treat hyperlipidemia by lowering choleste…

• FDA approval · 2024-04-04
  FDA Approved: PITAVASTATIN — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's supplemental application for pitavastatin calcium (pitavastatin) under ANDA205932.

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• FDA approval · 2024-04-02
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

  FDA has approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC to update labeling.

• 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 · 2024-03-20
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) by Sun Pharmaceutical Industries, expanding its approved ros…

• FDA approval · 2024-03-14
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, Inc.

• 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 · 2024-03-08
  FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved Regeneron's supplemental application for PRALUENT (alirocumab), confirming expanded regulatory authorization.

• 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 · 2024-02-16
  FDA Approved: ICOSAPENT ETHYL — Original Application (Northstar Rx LLC)

  FDA approved the original application for icospent ethyl (ICOSAPENT ETHYL) from Northstar Rx LLC, a generic version of the prescription ther…

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

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

• FDA approval · 2024-01-30
  FDA Approved: EZETIMIBE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ezetimibe from Sandoz Inc., authorizing the continued availability of a generic ezetimibe produc…

• FDA approval · 2024-01-16
  FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)

  FDA approved Biocon Pharma's supplemental application for simvastatin (ANDA078034), approving a generic simvastatin product filing.

• 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…

• FDA approval · 2023-11-28
  FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) submitted by Sandoz Inc.

• FDA approval · 2023-11-22
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Rosuvastatin calcium from Rising Pharma Holdings, Inc., granting approval of a supplemental ANDA…

• FDA approval · 2023-11-22
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)

  FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, bringing a rosuvasta…

• FDA approval · 2023-10-30
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Inc, confirming approval of the generic formula…