Hyponatremia

• FDA approval · 2025-04-23
  FDA Approved: TOLVAPTAN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for tolvaptan (generic), enabling a generic version of the drug to be marketed.

• EMA approval · 2025-03-26
  EMA Authorised: Samsca (tolvaptan) — Otsuka Pharmaceutical Netherlands B.V.

  EMA authorised Samsca (tolvaptan) for the treatment of syndrome of inappropriate antidiuretic hormone secretion (SIADH), with Otsuka Pharmac…

• FDA approval · 2023-06-21
  FDA Approved: TOLVAPTAN — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves an original generic application for tolvaptan from Novadoz Pharmaceuticals LLC.

• FDA approval · 2022-11-08
  FDA Approved: TOLVAPTAN — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for tolvaptan by Apotex Corp., indicating a regulatory update to the generic product's approval (suc…

• FDA approval · 2022-09-06
  FDA Approved: TOLVAPTAN — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic version of tolvaptan under an Original Application (ANDA) filed by Ascend Laboratories, LLC.

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• FDA approval · 2022-09-06
  FDA Approved: TOLVAPTAN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' tolvaptan as a generic drug through an Original Application (ANDA). The product is indicated for the tr…

• FDA approval · 2022-02-15
  FDA Approved: TOLVAPTAN — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s original application for tolvaptan, a vasopressin V2 receptor antagonist, for the treatment of hyponatremia. T…

• FDA approval · 2021-07-16
  FDA Approved: TOLVAPTAN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' tolvaptan via an original (ANDA) application, indicating a generic tolvaptan product is approved.

• FDA approval · 2021-04-22
  FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Samsca (tolvaptan) from Otsuka America Pharmaceutical, Inc.

• FDA approval · 2020-05-19
  FDA Approved: TOLVAPTAN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories LLC's original ANDA for tolvaptan, a vasopressin V2 receptor antagonist, as a generic option for treating h…

• FDA approval · 2020-05-19
  FDA Approved: TOLVAPTAN — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s Abbreviated New Drug Application for tolvaptan, creating a generic version of the vasopressin V2 receptor antago…

• FDA approval · 2018-04-23
  FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Samsca (tolvaptan) from Otsuka America Pharmaceutical.

• FDA approval · 2017-06-01
  FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for SAMSCA (tolvaptan) from Otsuka America Pharmaceutical, Inc., likely updating labeling or expandi…

• FDA approval · 2014-02-28
  FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for SAMSCA (tolvaptan) filed by Otsuka America Pharmaceutical, Inc. The action updates the product l…

• FDA approval · 2009-05-19
  FDA Approved: SAMSCA — Original Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved Samsca (tolvaptan) from Otsuka America for the treatment of clinically significant hyponatremia in adults, including hyponatrem…