Familial Hypercholesterolemia

• 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 · 2019-05-07
  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 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 · 2019-04-12
  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 · 2019-04-02
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

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• FDA approval · 2019-03-22
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for the ezetimibe and simvastatin combination by Amneal, indicating a modification to an already-app…

• 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 · 2018-12-18
  FDA Approved: EZALLOR SPRINKLE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved EZALLOR SPRINKLE (rosuvastatin) under Sun Pharmaceutical Industries, Inc.'s Original Application, introducing a sprinkle-form r…

• 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 · 2018-05-21
  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 · 2018-02-28
  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 · 2017-08-04
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for Lovastatin (generic statin). The approval pertains to changes under the AND…

• 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 · 2017-06-12
  FDA Approved: EZETIMIBE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s original application for ezetimibe, a generic cholesterol-lowering medication.

• 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 · 2017-04-24
  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 · 2017-01-25
  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 · 2017-01-19
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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