Hypercholesterolemia

• FDA approval · 2022-07-26
  FDA Approved: EZETIMIBE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original ANDA for ezetimibe tablets, a generic version of Zetia used to treat hyperlipidemia. The appro…

• FDA approval · 2022-07-08
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approved the supplemental application for atorvastatin calcium from NIVAGEN Pharmaceuticals, Inc., authorizing the generic product.

• FDA approval · 2022-03-10
  FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approves a generic version of Colestipol Hydrochloride under an Original Application filed by Zydus Lifesciences Limited.

• FDA approval · 2022-03-03
  FDA Approved: NIACIN — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for NIACIN (nicotinic acid) from Macleods Pharmaceuticals Limited, establishing a generic version of t…

• FDA approval · 2021-10-19
  FDA Approved: CHOLEYSTYRAMINE LIGHT — Original Application (Ascend Laboratories, LLC)

  FDA approved CHOLEYSTYRAMINE LIGHT from Ascend Laboratories, LLC as an original ANDA product.

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• FDA approval · 2021-09-14
  FDA Approved: CHOLESTYRAMINE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for cholestyramine filed by Ajanta Pharma USA Inc., indicating an update to the product's approv…

• FDA approval · 2021-07-14
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Inc)

  The FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as a generic tablet under an Original Application (ANDA214659), authorizing …

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for fenofibrate submitted by NorthStar RxLLC.

• FDA approval · 2021-05-04
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA granted supplemental approval for atorvastatin calcium from Dr. Reddy's Laboratories Limited under an ANDA.

• FDA approval · 2021-03-15
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pravastatin sodium to allow Aurobindo Pharma Limited to market a generic pravastatin product in …

• FDA approval · 2021-03-09
  FDA Approved: CHOLESTYRAMINE — Original Application (Precision Dose, Inc.)

  FDA approved an original ANDA for cholestyramine from Precision Dose, Inc., providing a generic version of the bile acid sequestrant.

• FDA approval · 2021-03-05
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic pravastatin sodium, updating its regulatory status as an approved ge…

• FDA approval · 2021-02-01
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin). This represents an approved suppleme…

• FDA approval · 2021-01-15
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) manufactured by Mylan Pharmaceuticals Inc.

• FDA approval · 2020-12-17
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original-application generic fixed-dose combination of ezetimibe and simvastatin.

• FDA approval · 2020-10-23
  FDA Approved: EZETIMIBE — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved ScieGen Pharmaceuticals' original (ANDA) application for ezetimibe as a generic cholesterol-lowering medication.

• FDA approval · 2020-10-19
  FDA Approved: FENOFIBRATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic's generic fenofibrate under an original drug application, confirming its use for lipid disorders. Fenofibrate lowers tr…

• FDA approval · 2020-10-13
  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, granting approval for a generic ator…

• FDA approval · 2020-09-25
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's supplemental application for EZALLOR SPRINKLE (rosuvastatin), adding a sprinkle formulation to the rosuvas…

• FDA approval · 2020-09-25
  FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Fluvastatin (generic) under the ANDA.

• FDA approval · 2020-09-25
  FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Lovastatin (Carlsbad Technology, Inc.) to modify an existing ANDA product.

• FDA approval · 2020-09-15
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for fluvastatin sodium submitted by Mylan Pharmaceuticals, updating the approved ANDA product.

• FDA approval · 2020-07-15
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approved the original application for COLESEVELAM HYDROCHLORIDE (colesevelam hydrochloride) by Cranbury Pharmaceuticals, LLC.

• FDA approval · 2020-06-24
  FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA granted a supplemental approval for a generic pitavastatin product from Aurobindo Pharma Limited.

• FDA approval · 2020-06-15
  FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for simvastatin from Micro Labs Limited.