Syndrome of Inappropriate Antidiuretic Hormone Secretion
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EMA approval · 2026-01-09EMA Authorised: Tolvaptan Accord (tolvaptan) — Accord Healthcare S.L.U.
The EMA authorised Tolvaptan Accord for the treatment of Syndrome of inappropriate antidiuretic hormone secretion (SIADH); Accord Healthcare…
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EMA approval · 2025-03-26EMA 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…
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FDA approval · 2022-11-08FDA 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…
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FDA approval · 2022-09-06FDA 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 · 2022-02-15FDA 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…
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FDA approval · 2021-07-16FDA Approved: TOLVAPTAN — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' tolvaptan via an original (ANDA) application, indicating a generic tolvaptan product is approved.
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FDA approval · 2021-04-22FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for Samsca (tolvaptan) from Otsuka America Pharmaceutical, Inc.
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FDA approval · 2020-05-19FDA 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…
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FDA approval · 2018-04-23FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for Samsca (tolvaptan) from Otsuka America Pharmaceutical.
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FDA approval · 2017-06-01FDA 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…
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FDA approval · 2009-05-19FDA 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…