Atherosclerotic Cardiovascular Disease

• FDA approval · 2018-03-30
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare's atorvastatin calcium as an original application (ANDA) for a generic atorvastatin calcium product.

• FDA approval · 2018-02-28
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC. The action commonly updates labeling, indications,…

• FDA approval · 2017-12-22
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Ascend Laboratories, LLC)

  FDA approved an original application for a fixed-dose combination of ezetimibe and simvastatin by Ascend Laboratories, LLC.

• FDA approval · 2017-11-21
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's original application for a generic fixed-dose combination of ezetimibe and simvastatin (EZETIMIBE AND SIMVASTATIN). Th…

• FDA approval · 2017-09-11
  FDA Approved: GEMFIBROZIL — Supplemental Application (Cadila Pharmaceuticals Limited)

  The FDA approved a supplemental application for Gemfibrozil filed by Cadila Pharmaceuticals Limited.

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• FDA approval · 2017-07-11
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin product).

• FDA approval · 2017-06-30
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  FDA approved a supplemental application for pravastatin sodium submitted by Cipla USA Inc., indicating an approved modification to the gener…

• FDA approval · 2017-06-23
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for the combination drug amlodipine and atorvastatin. The product is intend…

• FDA approval · 2017-06-12
  FDA Approved: EZETIMIBE — Original Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a generic ezetimibe tablet from Quallent Pharmaceuticals Health LLC under ANDA204331. Ezetimibe lowers cholesterol and is u…

• FDA approval · 2017-05-25
  FDA Approved: COLESTID — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for COLESTID (colestipol hydrochloride) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2017-04-24
  FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for PRALUENT (alirocumab) submitted by Regeneron Pharmaceuticals, Inc., updating the product’s l…

• FDA approval · 2017-03-27
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's atorvastatin calcium as an original-application generic product.

• FDA approval · 2017-03-21
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Ascend Laboratories, LLC)

  FDA approves the original ANDA for rosuvastatin calcium from Ascend Laboratories, LLC, enabling the generic rosuvastatin calcium product to …

• FDA approval · 2017-02-03
  FDA Approved: PITAVASTATIN — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved an original ANDA for pitavastatin calcium from Upsher-Smith Laboratories, making a generic pitavastatin product available.

• FDA approval · 2017-02-02
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved an original ANDA for pravastatin sodium tablets from Aurobindo Pharma Limited, providing a generic option for cholesterol manag…

• FDA approval · 2017-01-25
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  The FDA page indicates a supplemental application for Repatha (evolocumab) submitted by Amgen USA Inc.; the submission status is AP.

• FDA approval · 2017-01-23
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Pravastatin Sodium (generic) from Teva Pharmaceuticals USA, Inc. The approval confirms the c…

• FDA approval · 2017-01-19
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

• FDA approval · 2017-01-03
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  FDA approved a supplemental application for REPATHA (evolocumab) submitted by Amgen USA Inc.

• FDA approval · 2016-12-20
  FDA Approved: PITAVASTATIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original Abbreviated New Drug Application for pitavastatin from Aurobindo Pharma Limited, enabling the generic to enter the…

• FDA approval · 2016-11-23
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals' rosuvastatin calcium as an original generic product (ANDA 207453) for lowering cholesterol.

• FDA approval · 2016-11-20
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pravastatin sodium from Aurobindo Pharma Limited (ANDA077793), authorizing continued marketing o…

• FDA approval · 2016-11-17
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's pravastatin sodium product via an Original Application (ANDA207068).

• FDA approval · 2016-10-31
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approved Cranbury Pharmaceuticals' rosuvastatin calcium through an Original Application for an Abbreviated New Drug Application (ANDA), …

• FDA approval · 2016-10-31
  FDA Approved: ROSUVASTATIN — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's original application for rosuvastatin as a generic product. Rosuvastatin is used to treat hyperlipidemia an…