End-stage Renal Disease

• EMA approval · 2026-03-24
  EMA Authorised: Velphoro (sucroferric oxyhydroxide) — Vifor Fresenius Medical Care Renal Pharma France

  The EMA authorized Velphoro (sucroferric oxyhydroxide) for the treatment of hyperphosphatemia in patients with chronic kidney disease on ren…

• EMA approval · 2025-07-02
  EMA Authorised: Idefirix (imlifidase) — Hansa Biopharma AB

  The EMA authorised Idefirix (imlifidase) from Hansa Biopharma AB for desensitization to enable kidney transplantation in highly sensitised p…

• FDA approval · 2025-03-13
  FDA Approved: LANTHANUM CARBONATE — Original Application (Ascend Laboratories, LLC)

  FDA approved the Original Application for LANTHANUM CARBONATE as a generic product, manufactured by Ascend Laboratories, LLC.

• FDA approval · 2024-12-11
  FDA Approved: LANTHANUM CARBONATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for lanthanum carbonate from Teva Pharmaceuticals USA, Inc. This action is a supplemental approval f…

• FDA approval · 2024-08-29
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

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• FDA approval · 2024-07-01
  FDA Approved: VELPHORO — Supplemental Application (Fresenius Medical Care Renal Therapies Group, LLC)

  The FDA approved a supplemental application for Velphoro (sucroferric oxyhydroxide) submitted by Fresenius Medical Care Renal Therapies Grou…

• FDA approval · 2024-04-22
  FDA Approved: EXTRANEAL — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Extraneal (icodextrin) from Vantive US Healthcare LLC.

• 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 · 2024-01-19
  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…

• 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 · 2023-06-06
  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 · 2023-06-05
  FDA Approved: DIANEAL PD-2 WITH DEXTROSE — Supplemental Application (Vantive US Healthcare LLC)

  The FDA approved a supplemental application for Dianeal PD-2 with Dextrose (a peritoneal dialysis solution) from Vantive US Healthcare LLC.

• 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: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2022-07-20
  FDA Approved: LANTHANUM CARBONATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Lanthanum carbonate.

• FDA approval · 2022-01-27
  FDA Approved: LANTHANUM CARBONATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's lanthanum carbonate generic product for reducing phosphate levels in patients with end-stage renal disease on dialysis. …

• FDA approval · 2021-02-11
  FDA Approved: PARSABIV — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PARSABIV (etelcalcetide) from Amgen, Inc., updating the labeling as part of the supplemental sub…

• FDA approval · 2021-01-26
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care de Mexico, S.A. de C.V.)

  FDA approves a supplemental application for DELFLEX, a dialysis solution containing dextrose monohydrate and electrolytes, manufactured by F…

• FDA approval · 2021-01-26
  FDA Approved: DELFLEX — Supplemental Application (Fresenius Medical Care North America)

  The FDA approved a supplemental application for DELFLEX, a dialysis solution from Fresenius Medical Care North America, to update its formul…

• FDA approval · 2020-12-28
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Sevelamer carbonate submitted by Exelan Pharmaceuticals Inc.

• FDA approval · 2020-09-15
  FDA Approved: DOXERCALCIFEROL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approves an original ANDA for doxercalciferol (generic) manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

• FDA approval · 2020-05-11
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for FOSRENOL (lanthanum carbonate) from Takeda Pharmaceuticals America, expanding its labeling.

• FDA approval · 2020-05-11
  FDA Approved: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2020-04-30
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Sevelamer carbonate submitted by Sanofi-Aventis U.S. LLC.