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Samsca FDA Approval History

FDA Approved: Yes (First approved May 19, 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 timeline 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

Further information

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