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Tolvaptan's status in the US clarified

This article was originally published in Scrip

Executive Summary

Otsukahas pointed out that the US FDAhas issued "complete response" letters for the company's oral vasopressin 2 antagonist, tolvaptan, and has not rejected the registration filing (Scrip No 3403/04, p 16). The agency has additional requirements for the hyponatremia NDA, which are unlikely to involve additional studies, while with the indication of treating worsening heart failure, it is likely that additional clinical studies will be required.






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