Atherosclerotic Cardiovascular Disease
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2020-04-20Clinical Trial Update: Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study [Phase 3]
Phase 3 trial update for a study on cardiovascular inflammation imaging in vascular inflammation and atherosclerotic cardiovascular disease;…
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FDA label_change · 2020-04-17FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin), updating the product label as part of a supplemental submission…
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FDA approval · 2020-04-07FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical's supplemental application for ROSUVASTATIN CALCIUM, a generic rosuvastatin calcium product, under approved …
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FDA approval · 2020-04-07FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for rosuvastatin from Camber Pharmaceuticals, a generic rosuvastatin product under an ANDA.
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CLINICAL_TRIALS trial_result · 2020-04-03Clinical Trial Update: Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant [Phase 3]
Phase 3 trial evaluating the efficacy and safety of bempedoic acid (ETC-1002) in hyperlipidemia patients intolerant to statins; study comple…
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FDA approval · 2020-03-12FDA Approved: ROSUVASTATIN — Supplemental Application (Accord Healthcare Inc.)
FDA approved the supplemental application for rosuvastatin from Accord Healthcare Inc., extending approval for the generic rosuvastatin prod…
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FDA approval · 2020-03-10FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cadila Pharmaceuticals Limited)
FDA approved the supplemental application for Rosuvastatin Calcium submitted by Cadila Pharmaceuticals Limited.
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Rosuvastatin Calcium from Torrent Pharmaceuticals Limited, expanding regulatory approval for thi…
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)
FDA approved Glenmark's supplemental application for rosuvastatin calcium, authorizing a generic rosuvastatin calcium product and expanding …
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)
FDA approves Westminster Pharmaceuticals' supplemental application for rosuvastatin calcium, confirming this rosuvastatin salt as an approve…
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Rosuvastatin Calcium from Rising Pharma Holdings, Inc., enabling this rosuvastatin calcium g…
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FDA approval · 2020-02-26FDA Approved: NEXLIZET — Original Application (Esperion Therapeutics, Inc.)
The FDA approved Nexlizet, a fixed-dose combination of bempedoic acid and ezetimibe, for adults with primary hyperlipidemia (including heter…
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FDA approval · 2020-02-21FDA Approved: NEXLETOL — Original Application (Esperion Therapeutics, Inc.)
FDA approved Nexletol (bempedoic acid) as an original application for adults with heterozygous familial hypercholesterolemia or established …
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FDA approval · 2020-02-21FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for Rosuvastatin Calcium from Quallent Pharmaceuticals Health LLC, establishing a generic rosuvastat…
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FDA approval · 2020-01-29FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)
The FDA approved a supplemental application for the generic fixed-dose combination ezetimibe and simvastatin by Dr. Reddy's Laboratories. Th…
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FDA approval · 2020-01-29FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for the ezetimibe and simvastatin fixed-dose combination developed by Amneal Pharmaceuticals NY LLC.
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FDA approval · 2020-01-29FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories LLC.
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FDA approval · 2020-01-24FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for a generic ezetimibe and simvastatin combination product, expanding access to this lipid…
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CLINICAL_TRIALS trial_result · 2019-12-30Clinical Trial Update: High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients [Phase 4]
A Phase 4 trial comparing high-intensity rosuvastatin to moderate-intensity rosuvastatin/ezetimibe in patients with atherosclerotic cardiova…
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FDA approval · 2019-11-04FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Zhejiang Yongtai Pharmaceutical Co., Ltd.)
FDA approves rosuvastatin calcium as a generic drug (Original Application) by Zhejiang Yongtai Pharmaceutical Co., Ltd.
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FDA approval · 2019-10-25FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)
The FDA approved a supplemental application for atorvastatin calcium from Novadoz Pharmaceuticals LLC, authorizing its continued availabilit…
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FDA approval · 2019-10-22FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited under an ANDA to enable continued mar…
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FDA approval · 2019-10-22FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, allowing the generic product to be m…
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FDA approval · 2019-10-21FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s Supplemental Application for atorvastatin calcium, making a generic atorvastatin calcium product an approv…
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FDA approval · 2019-10-18FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for ATORVASTATIN CALCIUM submitted by Zydus Lifesciences Limited (ANDA 206536).