Hyperlipidemia

• FDA approval · 2023-02-02
  FDA Approved: NIACIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for NIACIN (niacin) from Sun Pharmaceutical Industries, Inc. under ANDA200484.

• FDA approval · 2023-01-18
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved an original application for colesevelam hydrochloride by Amneal Pharmaceuticals of New York LLC, granting a generic version of …

• FDA approval · 2023-01-13
  FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Crestor (rosuvastatin) from AstraZeneca Pharmaceuticals LP.

• 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 · 2022-12-16
  FDA Approved: EZETIMIBE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for EZETIMIBE from Amneal Pharmaceuticals NY LLC.

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• FDA approval · 2022-12-16
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for the fixed-dose combination of ezetimibe and simvastatin from Ascend Laboratories, LLC.

• FDA approval · 2022-12-16
  FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for ezetimibe from Ascend Laboratories, LLC.

• FDA approval · 2022-11-29
  FDA Approved: NIACIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental ANDA for NIACIN (nicotinic acid) from Aurobindo Pharma Limited, authorizing the marketing of a generic NIACIN pr…

• FDA approval · 2022-11-23
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Biocon Pharma Inc.)

  FDA approval of Biocon Pharma Inc.'s atorvastatin calcium as an original generic application (ANDA) aligned to the reference product labelin…

• FDA approval · 2022-11-03
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Lepu Pharmaceutical Technology Co., Ltd.)

  FDA approves the original application for atorvastatin calcium (generic) from Lepu Pharmaceutical Technology Co., Ltd. The approval adds a g…

• FDA approval · 2022-11-02
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  FDA approved a supplemental application for Colesevelam hydrochloride (generic) from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2022-10-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)

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

• FDA approval · 2022-10-13
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental ANDA for pravastatin sodium, enabling a generic version of pravastatin.

• FDA approval · 2022-10-06
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' supplemental application for a generic fixed-dose combination of amlodipine and atorvastatin (amlodi…

• FDA approval · 2022-09-28
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  FDA approved a supplemental application for Colesevelam hydrochloride (generic Colesevelam) from Glenmark Pharmaceuticals, authorizing its c…

• FDA approval · 2022-09-27
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application from Apotex Corp. for a generic amlodipine/atorvastatin combination tablet.

• FDA approval · 2022-09-27
  FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application (ANDA) for Fenofibrate from Aurobindo Pharma Limited.

• FDA approval · 2022-08-31
  FDA Approved: SIMVASTATIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for simvastatin from XLCare Pharmaceuticals Inc., confirming approval for the generic drug under the…

• FDA approval · 2022-08-29
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under the ANDA framework, supporting continued regulatory stat…

• FDA approval · 2022-08-29
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for simvastatin, resulting in changes to the product's labeling and/or m…

• FDA approval · 2022-08-17
  FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for gemfibrozil by Exelan Pharmaceuticals, Inc., under an ANDA supplement.

• FDA approval · 2022-07-26
  FDA Approved: EZETIMIBE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original ANDA for ezetimibe tablets, a generic version of Zetia used to treat hyperlipidemia. The appro…

• FDA approval · 2022-07-08
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approved the supplemental application for atorvastatin calcium from NIVAGEN Pharmaceuticals, Inc., authorizing the generic product.

• FDA approval · 2022-06-06
  FDA Approved: LEQVIO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for LEQVIO (inclisiran) submitted by Novartis Pharmaceuticals Corporation.

• 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.