Familial Hypercholesterolemia

• 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 · 2012-12-30
  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 · 2012-11-30
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2012-11-28
  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.

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

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

• FDA approval · 2012-09-28
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Simvastatin from Accord Healthcare, Inc., updating the approval status under the ANDA.

• FDA approval · 2012-07-20
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  FDA approved a supplemental application for Pravastatin Sodium by Cipla USA Inc., marking an approved change to the product's approval.

• FDA approval · 2012-07-17
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as an original ANDA, enabling a generic atorvastatin calcium product.

• FDA approval · 2012-07-12
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)

  FDA approved a supplemental application for pravastatin sodium (Quallent), resulting in an approved change to the generic product.

• FDA approval · 2012-07-09
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for WELCHOL (colesevelam hydrochloride) from Cosette Pharmaceuticals. The approval updates labeling …

• FDA approval · 2012-06-12
  FDA Approved: FLUVASTATIN — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's generic fluvastatin as an original application, enabling marketing of a generic statin product.

• FDA approval · 2012-05-03
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Pravastatin Sodium from Aurobindo Pharma Limited, confirming continued approval of this generic …

• FDA approval · 2012-03-02
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC, completing the changes described in the supplemental …

• 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.

• 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 · 2011-02-22
  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 · 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 · 2010-09-08
  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 · 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 · 2009-03-27
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 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 · 2008-06-13
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) from Organon LLC.