Hyperlipidemia

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories LLC.

• FDA approval · 2020-01-24
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for a generic ezetimibe and simvastatin combination product, expanding access to this lipid…

• FDA approval · 2019-12-18
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the amlodipine besylate and atorvastatin calcium combination product, submitted by Prasco Labora…

• FDA approval · 2019-12-09
  FDA Approved: FENOFIBRATE — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application for fenofibrate (generic) under ANDA 202252.

• FDA approval · 2019-11-26
  FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Gemfibrozil submitted by Exelan Pharmaceuticals, Inc., likely updating the product labeling.

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• FDA approval · 2019-11-18
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Original Application (Apotex Corp.)

  FDA approved the original application for a generic fixed-dose combination of amlodipine and atorvastatin, manufactured by Apotex Corp., for…

• FDA approval · 2019-11-04
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Zhejiang Yongtai Pharmaceutical Co., Ltd.)

  FDA approves rosuvastatin calcium as a generic drug (Original Application) by Zhejiang Yongtai Pharmaceutical Co., Ltd.

• FDA approval · 2019-10-30
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for fenofibrate, bringing a generic fenofibrate product to approval status.

• FDA approval · 2019-10-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)

  The FDA approved a supplemental application for atorvastatin calcium from Novadoz Pharmaceuticals LLC, authorizing its continued availabilit…

• FDA approval · 2019-10-25
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's supplemental application for fenofibrate (generic fenofibrate) under ANDA209950, resulting …

• FDA approval · 2019-10-22
  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 under an ANDA to enable continued mar…

• FDA approval · 2019-10-22
  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, allowing the generic product to be m…

• FDA approval · 2019-10-21
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)

  The FDA approved Cipla USA Inc.'s Supplemental Application for atorvastatin calcium, making a generic atorvastatin calcium product an approv…

• FDA approval · 2019-10-18
  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 · 2019-10-18
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for ATORVASTATIN CALCIUM submitted by Zydus Lifesciences Limited (ANDA 206536).

• FDA approval · 2019-10-16
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for atorvastatin calcium, a generic statin used to treat high cholesterol, unde…

• FDA approval · 2019-10-11
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application to market atorvastatin calcium as a generic version of atorvastatin.

• FDA approval · 2019-10-07
  FDA Approved: COLESEVELAM — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for COLESEVELAM by Zydus Lifesciences Limited, establishing a generic form of colesevelam for choleste…

• FDA approval · 2019-09-26
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories, LLC (ANDA209222).

• FDA approval · 2019-09-23
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for fenofibrate (generic). This action grants an additional approval to the AND…

• FDA approval · 2019-09-23
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC (ANDA 200264), authorizing the gener…

• FDA approval · 2019-09-23
  FDA Approved: FENOFIBRATE — Supplemental Application (AvKARE)

  The FDA has approved a supplemental application for AvKARE's fenofibrate product, signaling an update to the approved formulation/manufactur…

• FDA approval · 2019-09-23
  FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for fenofibrate from Leading Pharma, LLC (ANDA).

• FDA approval · 2019-09-23
  FDA Approved: FENOFIBRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fenofibrate filed by Aurobindo Pharma Limited, approving changes to the generic fenofibrate prod…

• FDA approval · 2019-09-19
  FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for fenofibrate from Cipla USA Inc. The approval indicates an update or addition via a supplemental …