Familial Hypercholesterolemia

• FDA approval · 2021-02-23
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for EZETIMIBE AND SIMVASTATIN by Ascend Laboratories, LLC. The approval covers changes under the…

• FDA approval · 2021-02-01
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin). This represents an approved suppleme…

• FDA approval · 2021-01-15
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) manufactured by Mylan Pharmaceuticals Inc.

• FDA approval · 2020-10-23
  FDA Approved: EZETIMIBE — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved ScieGen Pharmaceuticals' original (ANDA) application for ezetimibe as a generic cholesterol-lowering medication.

• FDA approval · 2020-09-25
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's supplemental application for EZALLOR SPRINKLE (rosuvastatin), adding a sprinkle formulation to the rosuvas…

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• FDA approval · 2020-09-25
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

• FDA approval · 2020-09-15
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for fluvastatin sodium submitted by Mylan Pharmaceuticals, updating the approved ANDA product.

• FDA approval · 2020-08-19
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approves an original new application for atorvastatin calcium from NIVAGEN Pharmaceuticals, a generic version of atorvastatin indicated …

• FDA approval · 2020-05-21
  FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a Supplemental Application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP, updating the drug's labe…

• FDA approval · 2020-04-07
  FDA 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.

• FDA approval · 2020-03-12
  FDA 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…

• FDA approval · 2020-03-10
  FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Praluent (alirocumab) from Regeneron, enabling updated labeling for the drug.

• FDA approval · 2020-03-10
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved the supplemental application for Rosuvastatin Calcium submitted by Cadila Pharmaceuticals Limited.

• FDA approval · 2020-03-09
  FDA 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…

• FDA approval · 2020-03-09
  FDA 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 …

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approves Westminster Pharmaceuticals' supplemental application for rosuvastatin calcium, confirming this rosuvastatin salt as an approve…

• FDA approval · 2020-01-29
  FDA 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.

• FDA approval · 2020-01-24
  FDA 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…

• FDA approval · 2019-10-22
  FDA 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…

• FDA approval · 2019-10-21
  FDA 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…

• FDA approval · 2019-10-18
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for ATORVASTATIN CALCIUM submitted by Zydus Lifesciences Limited (ANDA 206536).

• 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 · 2019-10-07
  FDA Approved: COLESEVELAM — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for COLESEVELAM by Zydus Lifesciences Limited, establishing a generic form of colesevelam for choleste…

• 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.

• FDA approval · 2019-08-20
  FDA Approved: CHOLESTYRAMINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for Cholestyramine submitted by Zydus Pharmaceuticals (USA) Inc. under ANDA202901.