Hypercholesterolemia

• FDA approval · 2010-01-08
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Pravastatin Sodium (generic pravastatin) under the ANDA, authoriz…

• FDA approval · 2009-01-08
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

• FDA approval · 2008-11-06
  FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for CRESTOR (rosuvastatin) from AstraZeneca Pharmaceuticals LP. The approval updates the labeling to…

• FDA approval · 2008-03-14
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Lovastatin, finalizing changes to the generic product's approval terms and …

• FDA approval · 2008-02-26
  FDA Approved: SIMVASTATIN — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's generic simvastatin as an original ANDA, enabling marketing of a generic statin for lipid-lowering indicati…

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• FDA approval · 2008-01-15
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for pravastatin sodium by Aurobindo Pharma Limited, confirming a generic pravastatin product. The drug…

• FDA approval · 2008-01-08
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic pravastatin sodium tablets under Original Application, enabling a generic statin to enter the ma…

• FDA approval · 2007-03-16
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for pravastatin sodium submitted by Teva Pharmaceuticals USA, Inc. under ANDA 076056. The action rel…

• FDA approval · 2007-01-16
  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 · 2006-12-20
  FDA Approved: SIMVASTATIN — Original Application (NorthStar Rx LLC)

  The FDA approved an original application for simvastatin (generic) from NorthStar Rx LLC, making a generic version of simvastatin available.

• FDA approval · 2006-10-24
  FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved an original application for Colestipol hydrochloride, a bile acid sequestrant used to treat hyperlipidemia and hypercholesterol…

• FDA approval · 2006-10-23
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Quallent)

  FDA approves the original application (ANDA) for Pravastatin Sodium (generic pravastatin) from Quallent, establishing a generic statin produ…

• FDA approval · 2006-10-23
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approves Dr. Reddy's Laboratories Limited pravastatin sodium under an Original Application (ANDA). This marks a new generic product appr…

• FDA approval · 2006-10-03
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC. This document confirms the app…

• FDA approval · 2006-05-23
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  The FDA has approved a supplemental application for Zetia (ezetimibe) submitted by Organon LLC.

• FDA approval ·
  FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol

  FDA approves Lipfendra (enlicitide), the first oral PCSK9 inhibitor, to reduce LDL cholesterol in adults with hypercholesterolemia as an adj…