Atherosclerotic Cardiovascular Disease

• FDA approval · 2026-08-17
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)

  FDA supplemental approval for a rosuvastatin calcium product from Glenmark Pharmaceuticals Inc. USA.

• FDA approval · 2026-08-17
  FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA supplemental application approval for Camber Pharmaceuticals' rosuvastatin product.

• FDA approval · 2026-08-05
  FDA Approved: SIMVASTATIN — Supplemental Application (WATSON LABS TEVA)

  A supplemental application approval for simvastatin by Watson Labs Teva, indicating a formulation/label change under an ANDA submission.

• FDA approval · 2026-08-04
  FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)

  Supplemental approval for fenofibrate from Bostal LLC.

• FDA approval · 2026-07-31
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  Supplemental approval for rosuvastatin calcium by Rising Pharma Holdings, Inc..

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• FDA approval · 2025-08-06
  FDA Approved: ICOSAPENT ETHYL — Original Application (Vitruvias Therapeutics, Inc.)

  FDA approved the original application for ICOSAPENT ETHYL by Vitruvias Therapeutics, Inc., enabling a generic version of the triglyceride-lo…

• FDA approval · 2025-08-05
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s supplemental application for pravastatin sodium, authorizing continued marketing of the product as a stati…

• 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 · 2025-06-13
  FDA Approved: PITAVASTATIN — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for pitavastatin calcium by Teva Pharmaceuticals, updating/expanding the existing approval for this …

• FDA approval · 2025-04-10
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)

  The FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, granting approva…

• FDA approval · 2025-03-18
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Pravastatin Sodium by Aurobindo Pharma Limited.

• 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.

• 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 · 2025-02-24
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pravastatin sodium submitted by Aurobindo Pharma Limited. This action pertains to the generic pr…

• FDA approval · 2025-02-18
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)

  FDA approved a supplemental application for Pravastatin Sodium submitted by Quallent, indicating an approved change to the product under an …

• 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 · 2025-01-14
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Umedica Laboratories USA Inc.)

  The FDA granted supplemental approval for rosuvastatin calcium under an ANDA for Umedica Laboratories USA Inc., confirming the generic produ…

• FDA approval · 2025-01-10
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s supplemental application for atorvastatin calcium, authorizing its continued marketing as a generic statin…