Mixed Dyslipidemia

• FDA approval · 2023-03-27
  FDA Approved: FENOFIBRATE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved a supplemental application for fenofibrate from Westminster Pharmaceuticals, LLC, authorizing changes to the generic produc…

• CLINICAL_TRIALS trial_result · 2023-02-24
  Clinical Trial Update: Bezafibrate Plus Berberine in Mixed Dyslipidemia [Phase 3]

  Phase 3 trial of bezafibrate plus berberine in mixed dyslipidemia completed with results posted.

• FDA approval · 2023-01-03
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for atorvastatin calcium from Ascend Laboratories, LLC, approving the generic atorvastatin calci…

• FDA approval · 2022-05-25
  FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals’ supplemental application for fenofibrate, authorizing the marketing of a generic fenofibrate product.

• FDA approval · 2022-04-05
  FDA Approved: FENOFIBRATE — Supplemental Application (AvKARE)

  FDA approved a supplemental application for fenofibrate from AvKARE, granting approval for a change under the ANDA for this generic product.…

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• FDA approval · 2022-01-04
  FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fenofibrate from Mylan Pharmaceuticals, updating an approved generic product.

• FDA approval · 2021-12-22
  FDA Approved: LEQVIO — Original Application (Novartis Pharmaceuticals Corporation)

  FDA granted original approval for LEQVIO (inclisiran) from Novartis Pharmaceuticals Corporation. The drug lowers LDL cholesterol in adults w…

• CLINICAL_TRIALS trial_result · 2021-08-20
  Clinical Trial Update: Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia [Phase 3]

  Phase 3 trial in Chinese participants evaluating evolocumab added to background statin therapy for primary hypercholesterolemia and mixed dy…

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., updating the approved generic product.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.,)

  FDA approved a supplemental application for Fenofibrate submitted by Cipla USA Inc.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for fenofibrate by Glenmark Pharmaceuticals Inc., USA under ANDA205566, resulting in updated labelin…

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)

  FDA approved a supplemental application for Fenofibrate (FENOFIBRATE) submitted by Bostal LLC under ANDA207805.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for fenofibrate submitted by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s supplemental application for fenofibrate.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for fenofibrate by Chartwell RX, LLC.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for fenofibrate submitted by NorthStar RxLLC.

• FDA approval · 2021-06-03
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for fenofibrate from Alembic Pharmaceuticals Limited under an ANDA.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for fenofibrate submitted by Lupin Pharmaceuticals, Inc.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's supplemental application for fenofibrate (generic) under ANDA210782. The approval pertains to…

• FDA approval · 2021-05-17
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for atorvastatin calcium by Accord Healthcare Inc., authorizing the continued commercialization of t…

• FDA approval · 2021-05-14
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for fenofibrate (Amneal Pharmaceuticals NY LLC) under an ANDA.

• FDA approval · 2021-05-14
  FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)

  The FDA approved a supplemental application for fenofibrate submitted by Leading Pharma, LLC.

• FDA approval · 2021-02-10
  FDA Approved: FENOFIBRATE — Original Application (Bostal LLC)

  FDA approved the original application for fenofibrate by Bostal LLC, enabling the marketing of a generic fenofibrate product for lipid disor…