Familial Hypercholesterolemia

• FDA approval · 2025-06-26
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for pravastatin sodium from Dr. Reddy's Laboratories Limited. This pertains to a generic pravastatin…

• FDA approval · 2025-03-18
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)

  FDA approved a supplemental application for pravastatin sodium from Cipla USA Inc., authorizing changes to the existing generic product.

• FDA approval · 2025-03-17
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium, a generic statin, approving changes to the product's la…

• FDA approval · 2025-03-17
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for pravastatin sodium from Accord Healthcare Inc., supporting continued regulatory approval for thi…

• FDA approval · 2025-03-13
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)

  FDA approved a supplemental application for atorvastatin calcium filed by Novadoz Pharmaceuticals LLC.

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• FDA approval · 2025-03-12
  FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for rosuvastatin (generic rosuvastatin), authorizing its marketing in the Unit…

• FDA approval · 2025-03-11
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for atorvastatin calcium, expanding the availability of a generic statin product.

• FDA approval · 2025-02-24
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for pravastatin sodium from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2025-01-14
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for rosuvastatin calcium submitted by Sun Pharmaceutical Industries, Inc., approving an additional f…

• FDA approval · 2025-01-14
  FDA Approved: ROSUVASTATIN — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for rosuvastatin submitted by ScieGen Pharmaceuticals, enabling the marketing of a generic rosuv…

• FDA approval · 2025-01-14
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Rosuvastatin Calcium from Ascend Laboratories, LLC, supporting the continued availability of a r…

• FDA approval · 2024-12-17
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for atorvastatin calcium (generic) from Ascend Laboratories, LLC, for this ANDA, approving regulator…

• FDA approval · 2024-12-04
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., enabling the generic atorvastatin …

• FDA approval · 2024-11-20
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  The FDA approved a supplemental application for Repatha (evolocumab) submitted by Amgen USA Inc.

• FDA approval · 2024-11-06
  FDA Approved: ROSUVASTATIN — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for rosuvastatin by Macleods Pharmaceuticals Limited, establishing a generic rosuvastatin product. Thi…

• FDA approval · 2024-10-16
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for rosuvastatin calcium from Rising Pharma Holdings, Inc., granting approval for a generic rosu…

• FDA approval · 2024-10-15
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)

  FDA approved a supplemental application for rosuvastatin calcium from Glenmark Pharmaceuticals, confirming regulatory approval of this gener…

• FDA approval · 2024-10-11
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Colesevelam hydrochloride from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2024-09-23
  FDA Approved: EZETIMIBE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for ezetimibe submitted by Sandoz Inc, updating the approved ezetimibe product.

• FDA approval · 2024-08-20
  FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)

  FDA approves a supplemental application for Repatha (evolocumab) from Amgen USA Inc., authorizing changes related to its labeling/indication…

• FDA approval · 2024-07-26
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for atorvastatin calcium from Micro Labs Limited, updating the approval status of this generic stati…

• FDA approval · 2024-07-11
  FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Fluvastatin Sodium (generic) from Lannett Company, Inc., confirming regulatory approval for this…

• FDA approval · 2024-07-11
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for atorvastatin calcium from NorthStar RxLLC, resulting in the approval of a generic atorvastatin c…

• FDA approval · 2024-07-10
  FDA Approved: EZETIMIBE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for ezetimibe (ANDA 210859). This is a routine supplemental approval for a gen…

• FDA approval · 2024-07-10
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental ANDA for atorvastatin calcium, enabling Zydus Lifesciences Limited to market a generic atorvastatin calcium prod…