Hypercholesterolemia

• FDA approval · 2013-01-27
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  The FDA approved a supplemental application for atorvastatin calcium submitted by Sun Pharmaceutical Industries Inc.

• FDA approval · 2012-12-31
  FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Fluvastatin from Teva Pharmaceuticals USA, Inc. to update the product labeling (ANDA).

• FDA approval · 2012-12-29
  FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Simvastatin submitted by Micro Labs Limited.

• FDA approval · 2012-12-29
  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, enabling continued marketing of the …

• FDA approval · 2012-11-30
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lovastatin from Lupin Pharmaceuticals, Inc., under the ANDA program.

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• FDA approval · 2012-11-20
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for simvastatin from Lupin Pharmaceuticals, indicating approval of a generic-simvastatin product via…

• FDA approval · 2012-10-31
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

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

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

  FDA approves Dr. Reddy's Laboratories Limited's generic atorvastatin calcium for lipid-lowering therapy under an original ANDA.

• 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 · 2012-06-12
  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 · 2012-04-20
  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 · 2012-03-01
  FDA Approved: FENOFIBRATE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's original application (ANDA090859) for a generic fenofibrate product, authorizing its marketi…

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

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

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

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

• 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 · 2010-03-10
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe/simvastatin) submitted by Organon LLC.