Hyperlipidemia

• 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.

• FDA approval · 2020-06-12
  FDA Approved: FENOFIBRATE — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's fenofibrate Original Application (ANDA213864), authorizing a generic fenofibrate product. This marks an appro…

• FDA approval · 2020-05-21
  FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a Supplemental Application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP, updating the drug's labe…

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• FDA approval · 2020-05-12
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2020-05-12
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2020-05-05
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Simvastatin from NorthStar Rx LLC, approving the continued marketing of this generic statin.

• FDA approval · 2020-04-07
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's supplemental application for ROSUVASTATIN CALCIUM, a generic rosuvastatin calcium product, under approved …

• FDA approval · 2020-04-07
  FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for rosuvastatin from Camber Pharmaceuticals, a generic rosuvastatin product under an ANDA.

• FDA approval · 2020-04-06
  FDA Approved: CHOLESTYRAMINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA's original application for a generic cholestyramine product.

• FDA approval · 2020-03-18
  FDA Approved: FENOFIBRATE — Original Application (Laurus Labs Limited)

  The FDA approved Laurus Labs Limited's original application for a generic fenofibrate product, granting approval for a generic version of fe…

• FDA approval · 2020-03-16
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  The FDA approved a supplemental application for colesevelam hydrochloride (Glenmark Pharmaceuticals Inc., USA), updating the product's label…

• FDA approval · 2020-03-16
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Colesevelam hydrochloride by Ascend Laboratories, LLC.

• FDA approval · 2020-03-12
  FDA Approved: ROSUVASTATIN — Supplemental Application (Accord Healthcare Inc.)

  FDA approved the supplemental application for rosuvastatin from Accord Healthcare Inc., extending approval for the generic rosuvastatin prod…

• FDA approval · 2020-03-10
  FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Praluent (alirocumab) from Regeneron, enabling updated labeling for the drug.

• FDA approval · 2020-03-10
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved the supplemental application for Rosuvastatin Calcium submitted by Cadila Pharmaceuticals Limited.

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Rosuvastatin Calcium from Torrent Pharmaceuticals Limited, expanding regulatory approval for thi…

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)

  FDA approved Glenmark's supplemental application for rosuvastatin calcium, authorizing a generic rosuvastatin calcium product and expanding …

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approves Westminster Pharmaceuticals' supplemental application for rosuvastatin calcium, confirming this rosuvastatin salt as an approve…

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Rosuvastatin Calcium from Rising Pharma Holdings, Inc., enabling this rosuvastatin calcium g…

• FDA approval · 2020-02-26
  FDA Approved: NEXLIZET — Original Application (Esperion Therapeutics, Inc.)

  The FDA approved Nexlizet, a fixed-dose combination of bempedoic acid and ezetimibe, for adults with primary hyperlipidemia (including heter…

• FDA approval · 2020-02-21
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for Rosuvastatin Calcium from Quallent Pharmaceuticals Health LLC, establishing a generic rosuvastat…

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  The FDA approved a supplemental application for the generic fixed-dose combination ezetimibe and simvastatin by Dr. Reddy's Laboratories. Th…

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for the ezetimibe and simvastatin fixed-dose combination developed by Amneal Pharmaceuticals NY LLC.