Hyperlipidemia

• FDA approval · 2019-09-13
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Bionpharma Inc.)

  FDA approved a generic version of colesevelam hydrochloride (Colesevelam HCl) by Bionpharma Inc. under an original ANDA, for lipid-lowering …

• FDA approval · 2019-09-06
  FDA Approved: FENOFIBRATE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for fenofibrate by Dr. Reddy's Laboratories Inc., authorizing the product as a generic.

• FDA approval · 2019-08-22
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc., authorizing a change to the generic product.

• FDA approval · 2019-08-20
  FDA Approved: CHOLESTYRAMINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for Cholestyramine submitted by Zydus Pharmaceuticals (USA) Inc. under ANDA202901.

• FDA approval · 2019-08-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for fenofibrate by Mylan Pharmaceuticals, confirming continued access to this generic triglyceride-l…

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• FDA approval · 2019-08-09
  FDA Approved: FENOFIBRATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic's fenofibrate as an Original Application (ANDA). The generic fenofibrate is approved for treating lipid disorders such …

• FDA approval · 2019-08-07
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Rising Pharma Holdings, Inc.'s atorvastatin calcium film-coated tablets, granting regulatory app…

• FDA approval · 2019-08-07
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Simvastatin by NorthStar Rx LLC.

• FDA approval · 2019-06-27
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's ezetimibe and simvastatin as an original ANDA application, enabling generic availability.

• FDA approval · 2019-05-21
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., resulting in changes to …

• FDA approval · 2019-05-21
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA has approved Cosette Pharmaceuticals' supplemental application for Welchol (colesevelam hydrochloride). This action constitutes an a…

• FDA approval · 2019-05-16
  FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, Inc.

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for fenofibrate from Lupin Pharmaceuticals, Inc. under the drug’s existing approval.

• FDA approval · 2019-05-15
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc., marking a regulatory action on thi…

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., extending regulatory approval for the generic …

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.,)

  FDA approved a supplemental application for fenofibrate from Cipla USA Inc., authorizing an updated generic fenofibrate product.

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental ANDA for fenofibrate from Glenmark Pharmaceuticals Inc., USA, authorizing a generic fenofibrate product.

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)

  FDA approved a supplemental application for fenofibrate from Bostal LLC, indicating approved changes to the product's labeling/status.

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for fenofibrate, resulting in an approved modification to the product's label…

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for fenofibrate from Torrent Pharmaceuticals Limited, updating the product's labeling and approved i…

• FDA approval · 2019-05-15
  FDA Approved: FENOFIBRATE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for fenofibrate filed by Ajanta Pharma USA Inc., authorizing continued marketing of the product unde…

• FDA approval · 2019-05-13
  FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for fenofibrate from ANI Pharmaceuticals, Inc.

• FDA approval · 2019-05-10
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the generic amlodipine besylate and atorvastatin calcium combination (amlodipine and atorvastati…

• FDA approval · 2019-05-07
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Shandong New Time Pharmaceutical Co., Ltd.)

  FDA approved the original application for rosuvastatin calcium (generic rosuvastatin) from Shandong New Time Pharmaceutical Co., Ltd., expan…

• FDA approval · 2019-05-06
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved an original application for Colesevelam hydrochloride (generic) from Ascend Laboratories, LLC.