Hyperlipidemia

• FDA approval · 2024-01-31
  FDA Approved: FENOFIBRATE — Original Application (Chartwell RX, LLC.)

  FDA approved fenofibrate (generic) under Original Application ANDA211407 for Chartwell RX, LLC. This marks the approval of a first generic v…

• 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.

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• 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…

• FDA approval · 2023-10-17
  FDA Approved: EZETIMIBE — Supplemental Application (Ohm Laboratories Inc.)

  FDA supplemental approval of a generic ezetimibe product by Ohm Laboratories Inc.

• FDA approval · 2023-10-17
  FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for EZETIMIBE filed by Quallent Pharmaceuticals Health LLC, approving a change to the marketed EZETI…

• FDA approval · 2023-10-17
  FDA Approved: EZETIMIBE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for EZETIMIBE from Aurobindo Pharma Limited.

• FDA approval · 2023-10-17
  FDA Approved: EZETIMIBE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  The FDA approved a supplemental application for ezetimibe by ScieGen Pharmaceuticals Inc.

• FDA approval · 2023-10-16
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved the original application for atorvastatin calcium from Cadila Pharmaceuticals Limited. This generic statin is used to treat hyp…

• FDA approval · 2023-10-04
  FDA Approved: COLESEVELAM HCL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Colesevelam HCl submitted by Ascend Laboratories, LLC, as part of the generic drug approval …

• FDA approval · 2023-09-20
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fenofibric acid from Aurobindo Pharma Limited, updating the product’s labeling as part of the su…

• FDA approval · 2023-09-20
  FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)

  FDA approved a supplemental application for Nexlizet (bempedoic acid and ezetimibe) submitted by Esperion Therapeutics, Inc.

• FDA approval · 2023-09-12
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (NorthStar RxLLC)

  FDA approved the Original Application for atorvastatin calcium from NorthStar RxLLC, enabling a generic atorvastatin calcium product to ente…

• FDA approval · 2023-09-07
  FDA Approved: FENOFIBRATE — Original Application (Creekwood Pharmaceuticals LLC)

  The FDA approved Creekwood Pharmaceuticals LLC's original ANDA for a generic fenofibrate product.

• FDA approval · 2023-08-22
  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, authorizing a generi…

• FDA approval · 2023-08-09
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a Supplemental Application for ZOCOR (simvastatin) submitted by Organon LLC.

• FDA approval · 2023-07-31
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.

• FDA approval · 2023-07-31
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  The FDA approves Accord Healthcare, Inc.'s supplemental application for simvastatin (ANDA 078155), authorizing the continued marketing of th…

• FDA approval · 2023-07-26
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Colesevelam hydrochloride (ANDA 209946) submitted by Cranbury Pharmaceuticals, LLC.

• FDA approval · 2023-07-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Quallent)

  FDA approved a supplemental application for atorvastatin calcium from Quallent, indicating a new approval-related action for this generic st…