Atherosclerotic Cardiovascular Disease

• FDA approval · 2007-05-11
  FDA Approved: SIMVASTATIN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original ANDA for simvastatin (generic). The approval adds a generic option for lowering cholesterol in …

• 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 · 2006-11-27
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

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• 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 · 2006-06-23
  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 · 2006-05-23
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

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