Atherosclerotic Cardiovascular Disease

• FDA approval · 2014-12-01
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lovastatin by Lupin Pharmaceuticals, Inc., resulting in regulatory approval related to the gener…

• FDA approval · 2014-12-01
  FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Lovastatin from Carlsbad Technology, Inc., expanding access to a generic statin.

• FDA approval · 2014-11-25
  FDA Approved: SIMVASTATIN — Original Application (XLCare Pharmaceuticals Inc.)

  The FDA approved the original application for SIMVASTATIN from XLCare Pharmaceuticals Inc., granting marketing authorization for a generic s…

• FDA approval · 2014-11-05
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s supplemental application for simvastatin (generic statin).

• FDA approval · 2014-11-05
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium (generic) from Dr. Reddy's Laboratories Limited. This document confirms the…

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• FDA approval · 2014-11-05
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.

• FDA approval · 2014-11-05
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for simvastatin, updating the approved generic product.

• FDA approval · 2014-11-04
  FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for simvastatin by Micro Labs Limited under ANDA090383, updating the regulatory status of the approv…

• FDA approval · 2014-11-04
  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, confirming approval of a generic ato…

• FDA approval · 2014-11-03
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for pravastatin sodium from Dr. Reddy's Laboratories Limited.

• FDA approval · 2014-11-03
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium, indicating regulatory approval for changes to this …

• FDA approval · 2014-10-26
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for ATORVASTATIN CALCIUM from Mylan Pharmaceuticals Inc., granting approval of a generic atorvastati…

• FDA approval · 2014-10-16
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  The FDA approved Cipla USA Inc.'s supplemental application for pravastatin sodium, confirming approval of a generic pravastatin product.

• FDA approval · 2014-09-30
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZETIA (ezetimibe) submitted by Organon LLC. The approval updates the product labeling to reflect…

• FDA approval · 2014-09-23
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc.

• FDA approval · 2014-09-23
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atorvastatin calcium by Mylan Pharmaceuticals, confirming the approval of a generic version of t…

• FDA approval · 2014-08-14
  FDA Approved: VASCEPA — Supplemental Application (Amarin Pharma Inc.)

  The FDA approved a supplemental application for Vascepa (icosapent ethyl) submitted by Amarin Pharma Inc., resulting in a labeling update re…

• FDA approval · 2014-07-28
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for the fixed-dose combination of amlodipine and atorvastatin (amlodipi…

• FDA approval · 2014-07-01
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  The FDA approved a supplemental application for Pravastatin Sodium by Cipla USA Inc.

• FDA approval · 2014-06-11
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application to authorize a generic clopidogrel bisulfate product from Aurobindo Pharma Limited.

• FDA approval · 2014-03-20
  FDA Approved: NIACIN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original abbreviated new drug application for NIACIN, a generic nicotinic acid product.

• FDA approval · 2014-02-26
  FDA Approved: VASCEPA — Supplemental Application (Amarin Pharma Inc.)

  FDA approves a supplemental application for Vascepa (icosapent ethyl), expanding its labeling to address cardiovascular risk reduction in ad…

• CLINICAL_TRIALS trial_result · 2014-02-06
  Clinical Trial Update: A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients [Phase 2]

  Phase 2 single ascending-dose study of reconstituted high-density lipoprotein CSL112 in patients with stable atherothrombotic disease assess…

• FDA approval · 2013-11-29
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves an original ANDA for AMLODIPINE AND ATORVASTATIN (Mylan Pharmaceuticals Inc.), a generic fixed-dose combination product.

• FDA approval · 2013-10-25
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC to the existing NDA.