Hyperkalemia

• EMA approval · 2025-09-03
  EMA Authorised: Lokelma (sodium zirconium cyclosilicate) — AstraZeneca AB

  The EMA authorised Lokelma (sodium zirconium cyclosilicate) from AstraZeneca AB for the treatment of hyperkalemia in the European Union.

• FDA approval · 2025-06-10
  FDA Approved: SODIUM POLYSTYRENE SULFONATE — Original Application (Burel Pharmaceuticals, LLC)

  FDA approved the original application for sodium polystyrene sulfonate, a generic version by Burel Pharmaceuticals, LLC, for the management …

• EMA approval · 2024-06-11
  EMA Authorised: Veltassa (patiromer sorbitex calcium) — Vifor Fresenius Medical Care Renal Pharma France

  The European Medicines Agency authorised Veltassa (patiromer sorbitex calcium) for the treatment of hyperkalemia; the marketing authorizatio…

• FDA approval · 2024-05-03
  FDA Approved: KIONEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for KIONEX (sodium polystyrene sulfonate) submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2024-02-08
  FDA Approved: LOKELMA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for LOKELMA (sodium zirconium cyclosilicate) from AstraZeneca, indicating an update or expansion to …

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• 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.

• FDA approval · 2023-03-27
  FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)

  FDA approved a supplemental application for VELTASSA (patiromer) submitted by Vifor Pharma, Inc., formalizing updates to the product labelin…

• FDA approval · 2022-10-18
  FDA Approved: KIONEX — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for KIONEX (sodium polystyrene sulfonate) from ANI Pharmaceuticals, Inc.

• FDA approval · 2022-10-17
  FDA Approved: CALCIUM GLUCONATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for CALCIUM GLUCONATE from Fresenius Kabi USA, LLC.

• FDA approval · 2022-09-30
  FDA Approved: LOKELMA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA has approved a supplemental application for Lokelma (sodium zirconium cyclosilicate) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2021-12-22
  FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)

  The FDA approved a supplemental application for VELTASSA (patiromer) from Vifor Pharma, Inc., resulting in an updated labeling for the produ…

• FDA approval · 2021-05-14
  FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)

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

• FDA approval · 2020-04-24
  FDA Approved: LOKELMA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for LOKELMA (sodium zirconium cyclosilicate) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2020-02-25
  FDA Approved: SODIUM POLYSTYRENE SULFONATE — Supplemental Application (PuraCap Laboratories, LLC)

  FDA approves a supplemental application for sodium polystyrene sulfonate from PuraCap Laboratories, LLC.

• FDA approval · 2020-02-21
  FDA Approved: SODIUM POLYSTYRENE SULFONATE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Sodium polystyrene sulfonate by Chartwell RX, LLC under the referenced ANDA.

• FDA approval · 2020-02-21
  FDA Approved: SODIUM POLYSTYRENE SULFONATE — Supplemental Application (KVK-Tech, Inc.)

  FDA approves a supplemental application for sodium polystyrene sulfonate submitted by KVK-Tech, Inc.

• FDA approval · 2020-02-21
  FDA Approved: SODIUM POLYSTYRENE SULFONATE — Supplemental Application (SUNRISE PHARMACEUTICAL, INC.)

  FDA approved a supplemental application for Sodium Polystyrene Sulfonate from Sunrise Pharmaceutical, Inc., resulting in an approved generic…

• FDA approval · 2018-05-18
  FDA Approved: LOKELMA — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved LOKELMA (sodium zirconium cyclosilicate) through its original NDA for the treatment of hyperkalemia.

• FDA approval · 2018-05-02
  FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)

  FDA approved a supplemental application for VELTASSA (patiromer) from Vifor Pharma, Inc., authorizing changes related to its labeling/indica…

• FDA approval · 2017-06-15
  FDA Approved: CALCIUM GLUCONATE — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's calcium gluconate product under an original NDA.

• FDA approval · 2016-11-25
  FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)

  The FDA has approved a supplemental application for VELTASSA (patiromer) filed by Vifor Pharma, Inc. VELTASSA is used to treat hyperkalemia.

• FDA approval · 2016-06-16
  FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)

  FDA approved a supplemental application for VELTASSA (patiromer) from Vifor Pharma, expanding its labeling.

• FDA approval · 2016-05-10
  FDA Approved: VELTASSA — Supplemental Application (Vifor Pharma, Inc.)

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

• FDA approval · 2016-02-18
  FDA Approved: SODIUM POLYSTYRENE SULFONATE — Original Application (Chartwell RX, LLC)

  FDA approved an original ANDA for sodium polystyrene sulfonate from Chartwell RX, LLC, establishing a generic product for the treatment of h…

• FDA approval · 2015-10-21
  FDA Approved: VELTASSA — Original Application (Vifor Pharma, Inc.)

  FDA approved VELTASSA (patiromer) from Vifor Pharma via the original NDA for the treatment of hyperkalemia.