Hyponatremia

U.S. FDA grants approval for investigational drug to treat hyponatremia

Published in Obesity and Diabetes Week, December 27th, 2004

Yamanouchi Pharmaceutical Co., Ltd. announced that its U.S. subsidiary, Yamanouchi Pharma America Inc. (YPA), Paramus, New Jersey, has received an approvable letter for YM087, an investigational drug to treat hyponatremia, from the U.S. Food and Drug Administration (FDA).

The letter outlines the conditions for marketing approval, which include a submission of additional safety data.

YM087, generic drug conivaptan hydrochloride, is an injectable dual V1a/V2 vasopressin receptor antagonist. It increases blood sodium levels in patients with euvolemic and hypervolemic hyponatremia by increasing excretion of free water without increasing the sodium output...

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Source: Obesity and Diabetes Week (2004-12-27)

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