Atherosclerotic Cardiovascular Disease

• FDA approval · 2023-03-13
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for pravastatin sodium from Accord Healthcare Inc., indicating regulatory action on this generic pro…

• FDA approval · 2023-03-08
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)

  The FDA approved Cipla USA Inc.'s supplemental application for atorvastatin calcium (generic atorvastatin calcium) under an ANDA.

• FDA approval · 2023-03-08
  FDA Approved: ICOSAPENT ETHYL — Original Application (Dr. Reddy's Laboratories, Inc.)

  FDA approved Dr. Reddy's Laboratories' generic icosapent ethyl through an original ANDA (ANDA 209499).

• 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…

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• 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.

• 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 · 2022-11-23
  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 · 2022-10-25
  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 · 2022-08-31
  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 · 2022-07-08
  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 · 2022-03-31
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for clopidogrel bisulfate (Radha Pharmaceuticals, Inc.) under an ANDA, confirming its status as a ge…

• FDA approval · 2022-03-07
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC.

• FDA approval · 2022-02-08
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Zhejiang Yongtai Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for Rosuvastatin Calcium from Zhejiang Yongtai Pharmaceutical Co., Ltd., resulting in an approved su…

• FDA approval · 2022-02-02
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for the ezetimibe and simvastatin combination product. This action updates the product's labeling fo…

• FDA approval · 2021-11-30
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) from Rising Pharma Holdings, Inc., confirming approv…

• FDA approval · 2021-09-15
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2021-08-31
  FDA Approved: SIMVASTATIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for simvastatin submitted by XLCare Pharmaceuticals Inc., approving changes under the ANDA.

• FDA approval · 2021-07-14
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Inc)

  The FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as a generic tablet under an Original Application (ANDA214659), authorizing …

• 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…