Atherosclerotic Cardiovascular Disease

Top drugs studied for this disease

All Approvals Safety alerts Label changes Trial results Research Guidance Withdrawals

FDA approval · 2023-12-13
FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)
The FDA approved a supplemental application for Nexlizet, the fixed-dose combination of bempedoic acid and ezetimibe from Esperion Therapeut…
FDA approval · 2023-11-28
FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) submitted by Sandoz Inc.
FDA approval · 2023-11-22
FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Rosuvastatin calcium from Rising Pharma Holdings, Inc., granting approval of a supplemental ANDA…
FDA approval · 2023-11-22
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, bringing a rosuvasta…
FDA approval · 2023-10-30
FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Inc, confirming approval of the generic formula…
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FDA approval · 2023-10-17
FDA Approved: EZETIMIBE — Supplemental Application (Ohm Laboratories Inc.)
FDA supplemental approval of a generic ezetimibe product by Ohm Laboratories Inc.
FDA approval · 2023-10-17
FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for EZETIMIBE filed by Quallent Pharmaceuticals Health LLC, approving a change to the marketed EZETI…
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: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)
FDA approved a supplemental application for Nexlizet (bempedoic acid and ezetimibe) submitted by Esperion Therapeutics, Inc.
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 · 2023-08-22
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.
CLINICAL_TRIALS trial_result · 2023-08-04
Clinical Trial Update: Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer [Phase 4]
A phase 4 clinical trial update evaluating a PCSK9 inhibitor in patients at very high risk of ASCVD and cancer.
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 · 2023-07-25
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 · 2023-07-14
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.