Hyperlipidemia

• FDA approval · 2010-09-14
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) filed by Cosette Pharmaceuticals, Inc.

• FDA approval · 2010-09-13
  FDA Approved: GEMFIBROZIL — Original Application (Northstar RxLLC)

  FDA approved the original ANDA for gemfibrozil from Northstar RxLLC, providing a generic version of the lipid-lowering drug.

• FDA approval · 2010-09-08
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC. The approval indicates an approved modification to th…

• 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.

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• FDA approval · 2010-04-30
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., authorizing changes to the approved product under …

• 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 · 2010-02-17
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories to market a generic fixed-dose combination of amlodipine besylate and atorv…

• 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…

• FDA approval · 2010-01-04
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P. under the ANDA process.

• 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 · 2009-10-02
  FDA Approved: WELCHOL — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' original NDA for Welchol (colesevelam hydrochloride). Welchol is a bile acid sequestrant used to treat…

• FDA approval · 2009-08-03
  FDA Approved: LIVALO — Original Application (Kowa Pharmaceuticals America, Inc.)

  FDA approved LIVALO (pitavastatin calcium) from Kowa Pharmaceuticals America, Inc. as an original NDA (NDA022363) for the treatment of hyper…

• 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 · 2009-07-20
  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 · 2009-07-14
  FDA Approved: LOPID — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Lopid (gemfibrozil) filed by the Parke-Davis division of Pfizer Inc. The action updates the …

• 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 · 2008-12-15
  FDA Approved: FENOFIBRIC ACID — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved fenofibric acid under an Original Application by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2008-12-12
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc., authorizing an update to the produ…

• 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.