Hyperlipidemia

• FDA approval · 2023-07-20
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Zetia (ezetimibe) submitted by Organon LLC.

• FDA approval · 2023-07-20
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Biocon Pharma Inc.)

  FDA issued a supplemental approval for atorvastatin calcium from Biocon Pharma Inc. under an ANDA.

• FDA approval · 2023-07-19
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Fenofibric Acid by Micro Labs Limited.

• FDA approval · 2023-07-14
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for rosuvastatin calcium (rosuvastatin) from Ascend Laboratories, LLC.

• FDA approval · 2023-07-13
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for ROSUVASTATIN CALCIUM from Torrent Pharmaceuticals Limited, confirming regulatory approval for th…

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• FDA approval · 2023-07-13
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental ANDA for rosuvastatin calcium, a generic rosuvastatin salt product.

• FDA approval · 2023-07-10
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for atorvastatin calcium film-coated tablets from Rising Pharma Holdings, Inc., supporting a gen…

• FDA approval · 2023-07-07
  FDA Approved: LEQVIO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for LEQVIO (inclisiran) filed by Novartis Pharmaceuticals Corporation, authorizing changes to the pr…

• FDA approval · 2023-06-30
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for Colesevelam hydrochloride by Dr. Reddy's Laboratories, approving a generic version of the choles…

• FDA approval · 2023-06-21
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for fenofibric acid submitted by Leading Pharma, LLC.

• FDA approval · 2023-06-02
  FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pitavastatin from Aurobindo Pharma Limited (ANDA206015).

• FDA approval · 2023-05-31
  FDA Approved: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA supplemental approval for a generic fixed-dose combination of amlodipine besylate and atorvastatin calcium by Dr. Reddy's Laboratories I…

• FDA approval · 2023-04-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2023-04-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Limited.

• FDA approval · 2023-04-13
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic pravastatin sodium product by Aurobindo Pharma Limited, authorizing its continued …

• FDA approval · 2023-04-11
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental ANDA for Colesevelam Hydrochloride, allowing the marketing of a generic Colesevelam Hydrochloride produ…

• FDA approval · 2023-03-27
  FDA Approved: FENOFIBRATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' Fenofibrate supplemental application.

• FDA approval · 2023-03-27
  FDA Approved: FENOFIBRATE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved a supplemental application for fenofibrate from Westminster Pharmaceuticals, LLC, authorizing changes to the generic produc…

• FDA approval · 2023-03-24
  FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fenofibrate submitted by Mylan Pharmaceuticals Inc., for a generic fenofibrate product.

• FDA approval · 2023-03-20
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Pravastatin Sodium from Aurobindo Pharma Limited, confirming continued approval of this generic …

• FDA approval · 2023-03-14
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC.

• FDA approval · 2023-03-13
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for pravastatin sodium from Accord Healthcare Inc., indicating regulatory action on this generic pro…

• FDA approval · 2023-03-10
  FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' original-application approval for Colestipol hydrochloride, a generic cholesterol-lowering medicine used t…

• FDA approval · 2023-03-08
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)

  The FDA approved Cipla USA Inc.'s supplemental application for atorvastatin calcium (generic atorvastatin calcium) under an ANDA.

• FDA approval · 2023-02-02
  FDA Approved: NIACIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for NIACIN (nicotinic acid) from Sun Pharmaceutical Industries, Inc.