Familial Hypercholesterolemia

• 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 · 2024-06-14
  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 · 2024-04-30
  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 · 2024-04-02
  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…

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

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

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

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

• 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 · 2023-10-17
  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 · 2023-10-16
  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 · 2023-09-12
  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 · 2023-08-22
  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 · 2023-07-31
  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 · 2023-07-25
  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…

• FDA approval · 2023-07-20
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

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

• FDA approval · 2023-07-10
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for atorvastatin calcium film-coated tablets from Rising Pharma Holdings, Inc., supporting a gen…

• FDA approval · 2023-07-07
  FDA Approved: LEQVIO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for LEQVIO (inclisiran) filed by Novartis Pharmaceuticals Corporation, authorizing changes to the pr…