Atherosclerotic Cardiovascular Disease

• FDA approval · 2019-10-16
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for atorvastatin calcium, a generic statin used to treat high cholesterol, unde…

• FDA approval · 2019-10-11
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application to market atorvastatin calcium as a generic version of atorvastatin.

• FDA label_change · 2019-10-04
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  This document records a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC, likely involving labeling…

• FDA approval · 2019-09-26
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories, LLC (ANDA209222).

• FDA approval · 2019-08-22
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc., authorizing a change to the generic product.

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• FDA approval · 2019-08-07
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Rising Pharma Holdings, Inc.'s atorvastatin calcium film-coated tablets, granting regulatory app…

• FDA approval · 2019-08-07
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Simvastatin by NorthStar Rx LLC.

• FDA approval · 2019-06-27
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's ezetimibe and simvastatin as an original ANDA application, enabling generic availability.

• CLINICAL_TRIALS trial_result · 2019-05-17
  Clinical Trial Update: Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) [Phase 2]

  Phase 2 trial evaluating ALN-PCSSC treatment on LDL-C in patients with atherosclerotic cardiovascular disease and familial hypercholesterole…

• FDA approval · 2019-05-16
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, Inc.

• FDA approval · 2019-05-07
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Shandong New Time Pharmaceutical Co., Ltd.)

  FDA approved the original application for rosuvastatin calcium (generic rosuvastatin) from Shandong New Time Pharmaceutical Co., Ltd., expan…

• FDA label_change · 2019-04-26
  FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved a supplemental application for PRALUENT (alirocumab) from Regeneron, updating the product labeling to reflect new information.

• FDA approval · 2019-04-24
  FDA Approved: ROSUVASTATIN — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original ANDA for a generic rosuvastatin product, manufactured by ScieGen Pharmaceuticals, Inc.

• FDA approval · 2019-04-16
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for the generic fixed-dose combination ezetimibe and simvastatin.

• FDA approval · 2019-04-12
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC.

• FDA approval · 2019-04-09
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Umedica Laboratories USA Inc.)

  FDA approved a generic rosuvastatin calcium product from Umedica Laboratories USA Inc. under an Original Application (ANDA).

• FDA approval · 2019-04-03
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  FDA approved Cranbury Pharmaceuticals, LLC's supplemental application for Rosuvastatin Calcium, authorizing a generic rosuvastatin calcium p…

• FDA approval · 2019-04-02
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.

• FDA label_change · 2019-03-27
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) by Sun Pharmaceutical Industries, Inc., related to this rosu…

• CLINICAL_TRIALS trial_result · 2019-03-18
  Clinical Trial Update: ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab [Phase 3]

  Phase 3 outcomes study evaluating cardiovascular outcomes after acute coronary syndrome during treatment with alirocumab (ODYSSEY Outcomes) …

• FDA approval · 2019-03-06
  FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)

  FDA approved Biocon Pharma Inc.'s supplemental application for simvastatin (ANDA 078034). The approval concerns Biocon's generic simvastatin…

• FDA approval · 2019-03-06
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc. for atorvastatin calcium as a generic product under an Original Application (ANDA).

• FDA approval · 2019-03-01
  FDA Approved: ROSUVASTATIN — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical, Inc.'s rosuvastatin as a generic product under an original application, enabling marketing of this s…

• CLINICAL_TRIALS research · 2019-02-21
  Clinical Trial Update: Plaque Calcium Characterization and Ruptured Plaques

  An update on a clinical trial investigating calcium characterization of atherosclerotic plaques and rupture in vulnerable plaques.

• FDA approval · 2019-02-15
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  FDA approved a supplemental application for REPATHA (evolocumab) filed by Amgen USA Inc., resulting in labeling updates.