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FDA Approves Astellas' VAPRISOL(R) For The Treatment Of Euvolemic Hyponatremia.

Publication: PR Newswire
Publication Date: 30-DEC-05 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
First arginine vasopressin (AVP) antagonist approved for the management of potentially life-threatening sodium/water imbalance

DEERFIELD, Ill., Dec. 30 /PRNewswire/ -- Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VAPRISOL(R) (investigational name: YM087, generic name: conivaptan hydrochloride injection), an arginine vasopressin (AVP) antagonist for the intravenous treatment of euvolemic hyponatremia in hospitalized patients. VAPRISOL, discovered and developed by Astellas, is the first drug specifically indicated for the treatment of euvolemic hyponatremia, a potentially life- threatening condition that occurs when the body's blood sodium level falls significantly below normal. The FDA also issued an approvable letter for VAPRISOL as a treatment for hypervolemic hyponatremia. Astellas plans on working closely with the FDA to obtain an approval for VAPRISOL's use in patients with hypervolemic hyponatremia.

Hyponatremia is estimated to affect up to 4 percent of hospitalized...

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