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Samsca Approval History

  • FDA approved: Yes (First approved May 19th, 2009)
  • Brand name: Samsca
  • Generic name: tolvaptan
  • Dosage form: Tablets
  • Company: Otsuka Pharmaceutical Development & Commercialization, Inc.
  • Treatment for: Hyponatremia

Samsca (tolvaptan) is an oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia.

Development History and FDA Approval Process for Samsca

May 22, 2009Approval FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
Jun 26, 2008U.S. Food and Drug Administration Advisory Committee Recommends Approval of Tolvaptan, an Investigational Treatment for Hyponatremia
Dec 21, 2007New Drug Application for Tolvaptan, Otsuka's Investigational NovelOral Treatment for Worsening Heart Failure and Hyponatremia,Accepted by the U.S. Food and Drug Administration

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