Chronic Kidney Disease

• FDA approval · 2024-04-30
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for sevelamer carbonate filed by Aurobindo Pharma Limited, enabling a supplemental approval for …

• FDA approval · 2024-04-25
  FDA Approved: SEVELAMER CARBONATE — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's generic sevelamer carbonate (ANDA 207291) for the treatment of hyperphosphatemia in adults with chronic kidne…

• FDA approval · 2024-04-10
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA granted supplemental approval for Sevelamer Carbonate from Macleods Pharmaceuticals Limited under an ANDA.

• FDA approval · 2024-04-02
  FDA Approved: FUROSEMIDE — Original Application (Devatis Inc.)

  FDA approved Devatis Inc.'s original application for a generic furosemide product, enabling its marketing in the United States.

• FDA approval · 2024-01-19
  FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Ferric Citrate by Mylan Pharmaceuticals Inc., marking regulatory authorization for an updated su…

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• FDA approval · 2024-01-19
  FDA Approved: RAYALDEE — Supplemental Application (OPKO Pharmaceuticals LLC)

  FDA approved a supplemental application for RAYALDEE (calcifediol) from OPKO Pharmaceuticals LLC under NDA 208010, authorizing changes to th…

• FDA approval · 2023-12-22
  FDA Approved: SEVELAMER HYDROCHLORIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for sevelamer hydrochloride submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2023-12-12
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Fosrenol (lanthanum carbonate) from Takeda Pharmaceuticals America, Inc., resulting in changes t…

• FDA approval · 2023-12-06
  FDA Approved: LANTHANUM CARBONATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for lanthanum carbonate (Cipla USA Inc.). This action updates the product's regulatory approval stat…

• FDA approval · 2023-10-17
  FDA Approved: XPHOZAH 10 MG — Original Application (Ardelyx, Inc.)

  FDA approved XPHOZAH (tenapanor) from Ardelyx in its original NDA for the treatment of hyperphosphatemia in adults with chronic kidney disea…

• FDA approval · 2023-10-02
  FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)

  FDA approved a supplemental application for VELTASSA (patiromer) submitted by Vifor Pharma, Inc.

• EMA approval · 2023-09-27
  EMA Authorised: Eporatio (epoetin theta) — Ratiopharm GmbH

  Authorised status for Eporatio (epoetin theta) by Ratiopharm GmbH for treatment areas including chronic kidney failure, anemia, and cancer.

• EMA approval · 2023-09-27
  EMA Authorised: Biopoin (epoetin theta) — Teva GmbH

  Biopoin (epoetin theta) has been authorised by the EMA for indications including chronic kidney failure, anemia, and cancer.

• FDA approval · 2023-09-08
  FDA Approved: SEVELAMER CARBONATE — Original Application (Strides Pharma Science Limited)

  FDA approved the original abbreviated new drug application for sevelamer carbonate from Strides Pharma Science Limited, a generic phosphate …

• FDA approval · 2023-07-24
  FDA Approved: BUMETANIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original ANDA for bumetanide, a loop diuretic used to treat edema and related conditions.

• FDA approval · 2023-07-11
  FDA Approved: SEVELAMER HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved an original ANDA for sevelamer hydrochloride by Aurobindo Pharma Limited, establishing a generic version of the phosphate binde…

• FDA approval · 2023-06-15
  FDA Approved: DOXERCALCIFEROL — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved an original application for doxercalciferol as a generic drug, expanding access to this vitamin D analog.

• FDA approval · 2023-06-06
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Sevelamer carbonate from Sanofi-Aventis U.S. LLC, indicating an updated labeling for the product…

• FDA approval · 2023-06-05
  FDA Approved: DIANEAL LOW CALCIUM WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Dianeal Low Calcium with Dextrose, a peritoneal dialysis solution, submitted by Vantive US H…

• FDA approval · 2023-05-26
  FDA Approved: SEVELAMER HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for sevelamer hydrochloride from Macleods Pharmaceuticals Limited, authorizing a generic phosphate bin…

• FDA approval · 2023-05-19
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (DR. REDDY'S LABORATORIES LIMITED)

  FDA approved a supplemental application for Sevelamer Carbonate submitted by Dr. Reddy's Laboratories Limited. Sevelamer carbonate is a phos…

• FDA approval · 2023-05-10
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) filed by Takeda Pharmaceuticals America, Inc., expanding the …

• FDA approval · 2023-05-10
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2023-05-10
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Fosrenol (lanthanum carbonate) by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2023-04-19
  FDA Approved: SEVELAMER CARBONATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's sevelamer carbonate as an original-application generic for treating hyperphosphatemia in pat…