Atherosclerotic Cardiovascular Disease

• 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 · 2012-06-12
  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 · 2012-05-29
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves the atorvastatin calcium generic product from Mylan (Original Application) for use in lowering cholesterol.

• FDA approval · 2012-05-29
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Quallent)

  The FDA approved Quallent's Abbreviated New Drug Application for atorvastatin calcium, establishing a generic atorvastatin calcium product. …

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• 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 · 2012-04-20
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  The FDA approves a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., resulting in a generic atorvas…

• FDA approval · 2012-04-11
  FDA Approved: FLUVASTATIN SODIUM — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved a generic version of fluvastatin sodium through an Original Application (ANDA) by Mylan Pharmaceuticals Inc.

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

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

• FDA approval · 2012-01-17
  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 · 2011-11-30
  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 · 2011-06-17
  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 · 2011-02-22
  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 · 2010-09-20
  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 · 2010-09-08
  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…