Hyperlipidemia

• FDA approval · 2021-02-16
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for pravastatin sodium (generic pravastatin) under ANDA 076056.

• FDA approval · 2021-02-11
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic Pravastatin Sodium product from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2021-02-10
  FDA Approved: FENOFIBRATE — Original Application (Bostal LLC)

  FDA approved the original application for fenofibrate by Bostal LLC, enabling the marketing of a generic fenofibrate product for lipid disor…

• FDA approval · 2021-02-02
  FDA Approved: FENOFIBRATE — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for fenofibrate submitted by Solco Healthcare US, LLC.

• 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…

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• 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 · 2021-01-13
  FDA Approved: GEMFIBROZIL — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the original ANDA for Gemfibrozil from XLCare Pharmaceuticals, granting approval for a generic version of the lipid-lowering dr…

• FDA approval · 2021-01-07
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium, manufactured by …

• FDA approval · 2021-01-06
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (KD Pharma USA, Inc.)

  The FDA approved a supplemental application for Omega-3-acid ethyl esters from KD Pharma USA, Inc., confirming continued approval of this ge…

• 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 · 2020-12-15
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium, manufactured by …

• FDA approval · 2020-12-10
  FDA Approved: LOPID — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Lopid (gemfibrozil) submitted by Parke-Davis Div of Pfizer Inc.

• 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: ZYPITAMAG — Supplemental Application (Medicure International Inc)

  The FDA has approved a supplemental application for ZYPITAMAG (pitavastatin magnesium) filed by Medicure International Inc.

• 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: VYTORIN — Supplemental Application (Organon LLC)

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

• 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 · 2020-09-25
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Fluvastatin Sodium (generic) filed by Mylan Pharmaceuticals Inc., enabling continued marketi…

• 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 · 2020-08-25
  FDA Approved: FENOFIBRATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Fenofibrate from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2020-08-19
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approves an original new application for atorvastatin calcium from NIVAGEN Pharmaceuticals, a generic version of atorvastatin indicated …

• FDA approval · 2020-07-29
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., indicating an approv…