Atherosclerotic Cardiovascular Disease

• 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.

• 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…

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• 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 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…

• 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.

• FDA approval · 2019-02-08
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves the first original application for atorvastatin calcium as a generic product from Novadoz Pharmaceuticals LLC.

• FDA approval · 2018-12-31
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin from NorthStar Rx LLC, updating the approved generic product's labeling/manufacturin…

• FDA approval · 2018-12-31
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for SIMVASTATIN from Accord Healthcare, Inc., updating the approved product. This action concerns a …

• FDA approval · 2018-12-21
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' atorvastatin calcium as an original generic application, authorizing a new generic version of atorvast…

• FDA approval · 2018-11-20
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for atorvastatin calcium from Zydus Lifesciences Limited, granting generic approval for lowering chole…

• FDA approval · 2018-08-22
  FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for PRALUENT (alirocumab) submitted by Regeneron Pharmaceuticals, Inc.

• FDA approval · 2018-06-18
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma's generic atorvastatin calcium (original ANDA) for lowering cholesterol and reducing cardiovascular risk.

• FDA approval · 2018-06-07
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Quallent)

  FDA approved a supplemental application for atorvastatin calcium from Quallent, authorizing continued approval of this generic statin produc…

• FDA approval · 2018-05-21
  FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)

  FDA has approved a supplemental application for ezetimibe from Ascend Laboratories, LLC, authorizing continued marketing under the ANDA.

• FDA approval · 2018-04-13
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma's pravastatin sodium as an original ANDA, authorizing a generic version of pravastatin for lowering cholesterol. …