Hyperphosphatemia

• 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 · 2023-05-26
  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: FOSRENOL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

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• 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…

• FDA approval · 2023-03-13
  FDA Approved: CALCIUM ACETATE — Original Application (SQUARE PHARMACEUTICALS LIMITED)

  The FDA approved Square Pharmaceuticals Limited's original application for calcium acetate, making a generic version of this phosphate binde…

• 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 · 2022-05-25
  FDA Approved: SEVELAMER CARBONATE FOR ORAL SUSPENSION — Supplemental Application (Dr. Reddys Laboratories Inc)

  FDA approved a supplemental application for Sevelamer carbonate for oral suspension from Dr. Reddy's Laboratories, enabling a generic formul…

• FDA approval · 2022-04-25
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals' supplemental application for sevelamer carbonate, enabling its generic product to be marketed.…

• FDA approval · 2022-04-05
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Sevelamer carbonate by Aurobindo Pharma Limited. This approval enables the generic product to be…

• FDA approval · 2022-02-07
  FDA Approved: SEVELAMER CARBONATE — Original Application (Micro Labs Limited)

  FDA approved the original ANDA for Sevelamer carbonate from Micro Labs Limited, enabling a generic version of the phosphate binder used to t…

• 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 · 2022-01-24
  FDA Approved: LANTHANUM CARBONATE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s generic lanthanum carbonate (original application) for the treatment of hyperphosphatemia in adults with chron…

• FDA approval · 2022-01-07
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Sevelamer Carbonate submitted by Bionpharma Inc.

• FDA approval · 2021-05-17
  FDA Approved: SEVELAMER CARBONATE — Original Application (Bionpharma Inc.)

  FDA approved the original application for sevelamer carbonate from Bionpharma Inc., a generic phosphate binder for managing hyperphosphatemi…

• FDA approval · 2021-03-10
  FDA Approved: FERRIC CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Ferric Citrate from Mylan Pharmaceuticals, approving a supplemental NDA for the product (NDA…

• FDA approval · 2021-01-04
  FDA Approved: SEVELAMER CARBONATE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Sevelamer Carbonate by Amneal Pharmaceuticals LLC.

• 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 · 2020-11-20
  FDA Approved: SEVELAMER CARBONATE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's generic sevelamer carbonate for the management of hyperphosphatemia in patients with c…

• FDA approval · 2020-11-17
  FDA Approved: CALCIUM ACETATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for calcium acetate capsules (667 mg) by Rising Pharma Holdings, Inc.

• FDA approval · 2020-08-11
  FDA Approved: SEVELAMER CARBONATE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for Sevelamer carbonate by Zydus Lifesciences Limited.

• 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.