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Yamanouchi submits hyponatremia agent

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Yamanouchi submits conivaptan NDA for treatment of hyponatremia in January. The first-in-class V1a/V2 vasopressin antagonist qualified for priority review, but the firm said it decided with FDA not to pursue the priority path in favor of an advisory committee review. There are no agents approved for hyponatremia, Yamanouchi says. Approximately 1% to 6% of hospitalized patients are hyponatremic, the majority of which have congestive heart failure...

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