Atherosclerotic Cardiovascular Disease

• FDA approval · 2010-06-01
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, Inc. The approval const…

• FDA approval · 2010-05-03
  FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Lovastatin submitted by Carlsbad Technology, Inc.

• FDA approval · 2010-04-08
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC. This action updates the product's labeling and…

• FDA approval · 2010-03-10
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

• 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…

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• FDA approval · 2009-11-06
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

• FDA approval · 2009-07-21
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

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

• FDA approval · 2009-04-03
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under ANDA 077691, granting approval for a change to the gener…

• FDA approval · 2009-03-27
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC.

• 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 · 2008-06-16
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental ANDA for a generic pravastatin sodium product, authorizing marketing of the generic statin.

• FDA approval · 2008-06-13
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

• FDA approval · 2008-06-05
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Zetia (ezetimibe) submitted by Organon LLC to update/expand aspects of its labeling.

• 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…

• 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 (Quallent)

  FDA approved a supplemental application for pravastatin sodium by Quallent, updating the approval status of this generic statin.

• 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 · 2007-11-01
  FDA Approved: LOVASTATIN — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' original ANDA for lovastatin, allowing a generic version of the statin to be marketed.

• 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.

• 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…