Hyperlipidemia

• FDA approval · 2017-06-30
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  FDA approved a supplemental application for pravastatin sodium submitted by Cipla USA Inc., indicating an approved modification to the gener…

• FDA approval · 2017-06-23
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for the combination drug amlodipine and atorvastatin. The product is intend…

• FDA approval · 2017-06-16
  FDA Approved: NIACIN — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's NIACIN generic (nicotinic acid) under ANDA 203899. The approval covers a generic niacin product indicated f…

• FDA approval · 2017-06-12
  FDA Approved: EZETIMIBE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s original application for ezetimibe, a generic cholesterol-lowering medication.

• FDA approval · 2017-06-12
  FDA Approved: EZETIMIBE — Original Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a generic ezetimibe tablet from Quallent Pharmaceuticals Health LLC under ANDA204331. Ezetimibe lowers cholesterol and is u…

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• FDA approval · 2017-06-12
  FDA Approved: EZETIMIBE — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's original application for ezetimibe, a generic cholesterol-lowering medication. The approval confirms marketing aut…

• FDA approval · 2017-05-25
  FDA Approved: COLESTID — Supplemental Application (Pharmacia & Upjohn Company LLC)

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

• FDA approval · 2017-05-12
  FDA Approved: FENOFIBRIC ACID — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved an original application for a generic fenofibric acid product manufactured by Alembic Pharmaceuticals Limited.

• FDA approval · 2017-04-26
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved a new generic fixed-dose combination of ezetimibe and simvastatin from Dr. Reddy's Laboratories Inc under an Original Applicati…

• FDA approval · 2017-04-25
  FDA Approved: CHOLESTYRAMINE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the generic cholestyramine (original application) from Zydus Pharmaceuticals (USA) Inc. This approval enables generic access to…

• FDA approval · 2017-04-24
  FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for PRALUENT (alirocumab) submitted by Regeneron Pharmaceuticals, Inc., updating the product’s l…

• FDA approval · 2017-04-07
  FDA Approved: FENOFIBRATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original application for Fenofibrate (generic), a lipid-lowering drug for hyperlipidemia, hypertriglyceridemia, …

• FDA approval · 2017-03-27
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's atorvastatin calcium as an original-application generic product.

• FDA approval · 2017-03-21
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Ascend Laboratories, LLC)

  FDA approves the original ANDA for rosuvastatin calcium from Ascend Laboratories, LLC, enabling the generic rosuvastatin calcium product to …

• FDA approval · 2017-02-03
  FDA Approved: PITAVASTATIN — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's original application for pitavastatin calcium, a generic statin indicated to treat hyperlipidemia by lowering cholestero…

• FDA approval · 2017-02-03
  FDA Approved: PITAVASTATIN — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved an original ANDA for pitavastatin calcium from Upsher-Smith Laboratories, making a generic pitavastatin product available.

• FDA approval · 2017-02-02
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved an original ANDA for pravastatin sodium tablets from Aurobindo Pharma Limited, providing a generic option for cholesterol manag…

• FDA approval · 2017-01-25
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  The FDA page indicates a supplemental application for Repatha (evolocumab) submitted by Amgen USA Inc.; the submission status is AP.

• FDA approval · 2017-01-23
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Pravastatin Sodium (generic) from Teva Pharmaceuticals USA, Inc. The approval confirms the c…

• FDA approval · 2017-01-19
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

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

• FDA approval · 2017-01-03
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  FDA approved a supplemental application for REPATHA (evolocumab) submitted by Amgen USA Inc.

• FDA approval · 2016-12-20
  FDA Approved: PITAVASTATIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original Abbreviated New Drug Application for pitavastatin from Aurobindo Pharma Limited, enabling the generic to enter the…

• FDA approval · 2016-12-15
  FDA Approved: FENOFIBRATE — Original Application (Cipla USA Inc.)

  This FDA entry records Cipla USA Inc.'s original approval of a generic fenofibrate tablet for lipid disorders.

• FDA approval · 2016-11-29
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for fenofibrate, indicating an approved labeling update or new indication under…

• FDA approval · 2016-11-23
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals' rosuvastatin calcium as an original generic product (ANDA 207453) for lowering cholesterol.