Familial Hypercholesterolemia

• 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 · 2007-12-28
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  FDA approved a supplemental application for pravastatin sodium submitted by Cipla USA Inc., signaling an additional regulatory approval for …

• FDA approval · 2007-11-26
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) from Organon LLC.

• FDA approval · 2007-10-05
  FDA Approved: LOVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Lovastatin submitted by Teva Pharmaceuticals USA, Inc.

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• FDA approval · 2007-09-26
  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 · 2007-05-11
  FDA Approved: PRAVASTATIN SODIUM — Original Application (CIPLA USA INC.)

  FDA approved a generic pravastatin sodium product (Pravastatin Sodium) from Cipla USA Inc. through an Original Application (ANDA). This mark…

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

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