Familial Hypercholesterolemia

• 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 · 2023-03-20
  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.

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• 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 · 2023-01-13
  FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Crestor (rosuvastatin) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2023-01-03
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for atorvastatin calcium from Ascend Laboratories, LLC, approving the generic atorvastatin calci…

• FDA approval · 2022-12-16
  FDA Approved: EZETIMIBE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

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

• FDA approval · 2022-12-16
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for the fixed-dose combination of ezetimibe and simvastatin from Ascend Laboratories, LLC.

• FDA approval · 2022-12-16
  FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for ezetimibe from Ascend Laboratories, LLC.

• FDA approval · 2022-11-23
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Biocon Pharma Inc.)

  FDA approval of Biocon Pharma Inc.'s atorvastatin calcium as an original generic application (ANDA) aligned to the reference product labelin…

• FDA approval · 2022-09-28
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  FDA approved a supplemental application for Colesevelam hydrochloride (generic Colesevelam) from Glenmark Pharmaceuticals, authorizing its c…

• FDA approval · 2022-08-31
  FDA Approved: SIMVASTATIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for simvastatin from XLCare Pharmaceuticals Inc., confirming approval for the generic drug under the…

• FDA approval · 2022-08-29
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under the ANDA framework, supporting continued regulatory stat…

• FDA approval · 2022-08-29
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for simvastatin, resulting in changes to the product's labeling and/or m…

• FDA approval · 2022-07-08
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approved the supplemental application for atorvastatin calcium from NIVAGEN Pharmaceuticals, Inc., authorizing the generic product.

• FDA approval · 2022-06-06
  FDA Approved: LEQVIO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for LEQVIO (inclisiran) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2022-03-07
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

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

• FDA approval · 2021-07-14
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Inc)

  The FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as a generic tablet under an Original Application (ANDA214659), authorizing …

• FDA approval · 2021-05-17
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for atorvastatin calcium by Accord Healthcare Inc., authorizing the continued commercialization of t…

• FDA approval · 2021-05-04
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA granted supplemental approval for atorvastatin calcium from Dr. Reddy's Laboratories Limited under an ANDA.

• FDA approval · 2021-03-17
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for a generic ezetimibe and simvastatin product from Dr. Reddy's Laboratories, authorizing its marke…

• FDA approval · 2021-03-05
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic pravastatin sodium, updating its regulatory status as an approved ge…

• FDA approval · 2021-02-26
  FDA Approved: REPATHA — Original Application (Amgen USA Inc.)

  FDA approved Repatha (evolocumab) from Amgen USA Inc. in an original application to lower LDL cholesterol in adults with familial hyperchole…