Hyperlipidemia

• FDA approval · 2018-05-18
  FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)

  FDA approved a supplemental application for Fenofibrate submitted by Bostal LLC under ANDA 207805. The approval confirms the continued appro…

• FDA approval · 2018-05-16
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a generic version of Colesevelam hydrochloride from Amneal Pharmaceuticals of New York LLC for lowering elevated LDL cholestero…

• FDA approval · 2018-04-30
  FDA Approved: FENOFIBRATE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' generic fenofibrate under an Original Application (ANDA 209504).

• FDA approval · 2018-04-25
  FDA Approved: LOPID — Supplemental Application (Parke-Davis Div of Pfizer Inc)

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

• FDA approval · 2018-04-20
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for fenofibrate from Amneal Pharmaceuticals NY LLC.

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• FDA approval · 2018-04-13
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma's pravastatin sodium as an original ANDA, authorizing a generic version of pravastatin for lowering cholesterol. …

• FDA approval · 2018-03-30
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare's atorvastatin calcium as an original application (ANDA) for a generic atorvastatin calcium product.

• FDA approval · 2018-03-19
  FDA Approved: FENOFIBRATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's fenofibrate generic under an original application (ANDA). This represents the approval of a fen…

• FDA approval · 2018-02-28
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC. The action commonly updates labeling, indications,…

• FDA approval · 2018-02-09
  FDA Approved: FENOFIBRATE — Original Application (AvKARE)

  FDA approved AvKARE's generic fenofibrate under an Original Application (ANDA 209951).

• FDA approval · 2018-02-01
  FDA Approved: NIACIN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for NIACIN, a generic niacin product intended to treat dyslipidemia and related lipid …

• FDA approval · 2017-12-22
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Ascend Laboratories, LLC)

  FDA approved an original application for a fixed-dose combination of ezetimibe and simvastatin by Ascend Laboratories, LLC.

• FDA approval · 2017-12-19
  FDA Approved: FENOFIBRATE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' original application for fenofibrate, authorizing the marketing of a generic fenofibrate product.

• FDA approval · 2017-11-22
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved the original application for rosuvastatin calcium (generic rosuvastatin calcium) from Quallent Pharmaceuticals Health LLC. The …

• FDA approval · 2017-11-21
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's original application for a generic fixed-dose combination of ezetimibe and simvastatin (EZETIMIBE AND SIMVASTATIN). Th…

• FDA approval · 2017-11-16
  FDA Approved: FENOFIBRATE — Original Application (Bostal LLC)

  FDA approved fenofibrate from Bostal LLC through an original application (ANDA 207805).

• FDA approval · 2017-10-30
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a fixed-dose combination of amlodipine and atorvastatin, manufactured by Prasco Laboratories, en…

• FDA approval · 2017-10-02
  FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Gemfibrozil submitted by Exelan Pharmaceuticals, Inc.

• FDA approval · 2017-09-18
  FDA Approved: GEMFIBROZIL — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental ANDA for Gemfibrozil from NorthStar Rx LLC, confirming regulatory approval of a generic Gemfibrozil product.

• FDA approval · 2017-09-11
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for fenofibrate from Lupin Pharmaceuticals, Inc., signaling an approved modification to the existing…

• FDA approval · 2017-09-11
  FDA Approved: GEMFIBROZIL — Supplemental Application (Cadila Pharmaceuticals Limited)

  The FDA approved a supplemental application for Gemfibrozil filed by Cadila Pharmaceuticals Limited.

• FDA approval · 2017-09-07
  FDA Approved: FENOFIBRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries, Inc.'s original ANDA for fenofibrate (generic fenofibrate).

• FDA approval · 2017-08-25
  FDA Approved: EZETIMIBE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for ezetimibe from Aurobindo Pharma Limited, enabling a generic version of the cholesterol-lowering dr…

• FDA approval · 2017-08-04
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for Lovastatin (generic statin). The approval pertains to changes under the AND…

• FDA approval · 2017-07-11
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin product).