Hyperlipidemia

• FDA approval · 2012-02-28
  FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) filed by Sandoz Inc.

• FDA approval · 2012-02-07
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

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

• FDA approval · 2012-01-17
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., enabling the generic atorvastatin …

• FDA approval · 2012-01-11
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s supplemental application for simvastatin (ANDA 078155).

• FDA approval · 2012-01-09
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for simvastatin from Lupin Pharmaceuticals, Inc.

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• FDA approval · 2012-01-03
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2012-01-03
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., indicating a labeling or…

• FDA approval · 2011-12-01
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) by Organon LLC, updating its labeling and indications.

• FDA approval · 2011-11-30
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Sun Pharmaceutical Industries Inc.)

  FDA approved Sun Pharmaceutical Industries Inc.'s atorvastatin calcium as an original Abbreviated New Drug Application (ANDA) generic produc…

• FDA approval · 2011-11-04
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA has approved a supplemental application for simvastatin submitted by Accord Healthcare, Inc., updating the approved product information …

• FDA approval · 2011-10-06
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

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

• FDA approval · 2011-09-27
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Pravastatin Sodium by Aurobindo Pharma Limited.

• FDA approval · 2011-09-16
  FDA Approved: SIMVASTATIN — Original Application (Micro Labs Limited)

  FDA approves Micro Labs Limited's original ANDA for simvastatin, a generic statin, enabling broader generic access in the U.S.

• FDA approval · 2011-07-26
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

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

• FDA approval · 2011-07-18
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved Cosette Pharmaceuticals' supplemental application for Welchol (colesevelam hydrochloride).

• FDA approval · 2011-06-27
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for fenofibrate from Amneal Pharmaceuticals NY LLC under the ANDA. The approval confirms changes…

• FDA approval · 2011-06-17
  FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) submitted by Sandoz Inc.

• FDA approval · 2011-06-16
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America. The approval expands th…

• FDA approval · 2011-05-08
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for fenofibrate (generic) from Rhodes Pharmaceuticals L.P., granting approval for an ANDA-relate…

• FDA approval · 2011-03-14
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for fenofibric acid submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2011-02-22
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic simvastatin (SIMVASTATIN), enabling its marketing as a generic stati…

• FDA approval · 2011-02-16
  FDA Approved: GEMFIBROZIL — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for gemfibrozil submitted by Northstar RxLLC under an ANDA.

• FDA approval · 2010-09-20
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc. (ANDA 078155).

• FDA approval · 2010-09-18
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC under ANDA077691. This action pertains to the appr…

• FDA approval · 2010-09-14
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC. Fenofibric acid is a lipid-lowe…