Atherosclerotic Cardiovascular Disease

• FDA approval · 2013-10-16
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

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

• CLINICAL_TRIALS guidance · 2013-10-10
  Clinical Trial Update: Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis [NA]

  A clinical trial update providing guidance on the use of intima-media thickness for primary prevention in relatives of patients with early-o…

• FDA approval · 2013-09-30
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for simvastatin submitted by Accord Healthcare, Inc.

• FDA approval · 2013-07-26
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for lovastatin, authorizing changes requested in the application (such as l…

• FDA approval · 2013-07-26
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)

  FDA approved a supplemental application for Pravastatin Sodium submitted by Quallent.

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• CLINICAL_TRIALS withdrawal · 2013-06-21
  Clinical Trial Update: Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis [Phase 2]

  A Phase 2 proof-of-concept trial of BMS-823778 for atherosclerotic cardiovascular disease has been withdrawn.

• FDA approval · 2013-04-29
  FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Lovastatin submitted by Carlsbad Technology, Inc. under ANDA 075991.

• FDA approval · 2013-04-18
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Pravastatin Sodium from Lupin Pharmaceuticals (ANDA 077917), formalizing approval of this generi…

• FDA approval · 2013-03-26
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Fluvastatin Sodium (generic Fluvastatin) from Mylan Pharmaceuticals Inc. (ANDA 090595), enabling…

• FDA approval · 2013-02-05
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pravastatin sodium from Aurobindo Pharma Limited, granting approval for a generic pravastatin so…

• FDA approval · 2013-02-05
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA issued an approval of a supplemental application for pravastatin sodium from Teva Pharmaceuticals USA, Inc. The action indicates a modif…

• FDA approval · 2013-01-27
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  The FDA approved a supplemental application for atorvastatin calcium submitted by Sun Pharmaceutical Industries Inc.

• FDA approval · 2013-01-27
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc., finalizing the regulatory action for this generic prod…

• FDA approval · 2012-12-31
  FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Fluvastatin from Teva Pharmaceuticals USA, Inc. to update the product labeling (ANDA).

• FDA approval · 2012-12-30
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals' supplemental application for pravastatin sodium, a generic statin, reflecting an approved update for this…

• FDA approval · 2012-12-29
  FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Simvastatin submitted by Micro Labs Limited.

• FDA approval · 2012-12-29
  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, enabling continued marketing of the …

• CLINICAL_TRIALS research · 2012-12-21
  Clinical Trial Update: A Multicenter Randomized Parallel-group Study to Investigate the Efficacy of a Combination of Rosuvastatin and Fenofibrate in the Patients With Diabetes or Atherosclerotic Vascular Diseases With Metabolic Syndrome

  A multicenter randomized parallel-group trial assessing the efficacy of combining rosuvastatin with fenofibrate in patients with diabetes or…

• FDA approval · 2012-11-30
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2012-11-30
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lovastatin from Lupin Pharmaceuticals, Inc., under the ANDA program.

• FDA approval · 2012-11-28
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC under ANDA077691. The approval expands the availab…

• FDA approval · 2012-11-27
  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.

• FDA approval · 2012-11-23
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application to authorize the generic atorvastatin calcium product from Dr. Reddy's Laboratories Limited.

• FDA approval · 2012-11-20
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for simvastatin from Lupin Pharmaceuticals, indicating approval of a generic-simvastatin product via…

• FDA approval · 2012-11-15
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

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