Atherosclerotic Cardiovascular Disease

• CLINICAL_TRIALS trial_result · 2023-07-11
  Clinical Trial Update: Effect of Evolocumab on Vascular Function [Phase 4]

  Phase 4 trial update investigating the effect of evolocumab on vascular function in atherosclerotic cardiovascular disease.

• 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 · 2023-06-02
  FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pitavastatin from Aurobindo Pharma Limited (ANDA206015).

• FDA approval · 2023-04-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium submitted by Dr. Reddy's Laboratories Limited.

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• FDA approval · 2023-04-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Limited.

• FDA approval · 2023-04-13
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic pravastatin sodium product by Aurobindo Pharma Limited, authorizing its continued …

• CLINICAL_TRIALS trial_result · 2023-03-24
  Clinical Trial Update: An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol [Phase 2]

  Phase 2 extension trial update for inclisiran in participants with cardiovascular disease and high cholesterol; study completed with results…

• FDA approval · 2023-03-20
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Pravastatin Sodium from Aurobindo Pharma Limited, confirming continued approval of this generic …

• FDA approval · 2023-03-14
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

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

• 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…

• 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 label_change · 2022-11-09
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIVALO (pitavastatin calcium) from Kowa Pharmaceuticals America, updating the drug's 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…