Hyperlipidemia

• 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.

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• 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 label_change · 2023-08-04
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) from Sun Pharmaceutical Industries.

• 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 label_change · 2023-07-27
  FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Crestor (rosuvastatin) from AstraZeneca, resulting in a labeling change to reflect new or re…

• 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…

• 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 · 2023-07-20
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Biocon Pharma Inc.)

  FDA issued a supplemental approval for atorvastatin calcium from Biocon Pharma Inc. under an ANDA.

• FDA approval · 2023-07-19
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Fenofibric Acid by Micro Labs Limited.

• FDA approval · 2023-07-14
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for rosuvastatin calcium (rosuvastatin) from Ascend Laboratories, LLC.

• FDA approval · 2023-07-13
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for ROSUVASTATIN CALCIUM from Torrent Pharmaceuticals Limited, confirming regulatory approval for th…

• FDA approval · 2023-07-13
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental ANDA for rosuvastatin calcium, a generic rosuvastatin salt product.

• 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…

• FDA approval · 2023-06-30
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for Colesevelam hydrochloride by Dr. Reddy's Laboratories, approving a generic version of the choles…

• FDA approval · 2023-06-21
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for fenofibric acid submitted by Leading Pharma, LLC.