Otsuka’s Samska gets advisory committee review
Executive Summary
FDA's Cardiovascular and Renal Drugs Advisory Committee will meet June 25 to evaluate Otsuka's hyponatremia drug Samska (tolvaptan) for patients with hypervolemic and euvolemic hyponatremia. The committee is concerned particularly with the change in sodium level as basis for drug approval. If approved, the selective V2-vasopressin receptor antagonist would be the first oral product in the vasopressin antagonist market. Otsuka is seeking a standard review of tolvaptan, putting the user fee goal date at Aug. 23
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FDA's Cardiovascular and Renal Drugs Advisory Committee will meet June 25 to evaluate Otsuka's hyponatremia drug Samska (tolvaptan) for patients with hypervolemic and euvolemic hyponatremia. The committee is concerned particularly with the change in sodium level as basis for drug approval. If approved, the selective V2-vasopressin receptor antagonist would be the first oral product in the vasopressin antagonist market. Otsuka is seeking a standard review of tolvaptan, putting the user fee goal date at Aug. 23. |