Hypercholesterolemia

• FDA approval · 2016-05-19
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cipla USA Inc.,)

  The FDA approved Cipla USA Inc.'s atorvastatin calcium tablet as an Original Application, enabling a generic atorvastatin calcium product to…

• FDA approval · 2016-01-27
  FDA Approved: FLUVASTATIN SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic fluvastatin sodium as an original ANDA, enabling its use to treat hyperlipidemia and reduce cardiovascular risk.

• FDA approval · 2015-10-06
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  The FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., granting regulatory approval f…

• EMA approval · 2015-07-24
  Praluent recommended for approval to lower cholesterol

  The European Medicines Agency recommended approval of Praluent (alirocumab) to lower cholesterol, pursuing a new indication.

• FDA approval · 2015-07-09
  FDA Approved: NIACIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for NIACIN (nicotinic acid) from Sun Pharmaceutical Industries, Inc., relating to an additional appr…

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• FDA approval · 2015-04-15
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Pravastatin Sodium submitted by Aurobindo Pharma Limited, approving this generic statin product.

• 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 · 2014-11-04
  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 · 2014-10-26
  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 · 2014-10-09
  FDA Approved: COLESTIPOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Colestipol hydrochloride by Amneal Pharmaceuticals of New York LLC.

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

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

• FDA approval · 2014-05-22
  FDA Approved: COLESTID — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for COLESTID (colestipol hydrochloride) submitted by Pharmacia & Upjohn Company LLC.

• 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 · 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.

• FDA approval · 2013-07-26
  FDA Approved: QUESTRAN — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for QUESTRAN (cholestyramine) from Endo USA, Inc., updating its labeling to reflect additional indic…

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

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

• FDA approval · 2013-04-22
  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 · 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 · 2013-02-05
  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…