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FDA approves sodium level drug, company says

/ Source: The Associated Press

The FDA has approved an intravenous drug for hospital patients suffering from potentially life-threateningly low sodium levels, the drug's manufacturer said Friday.

Astellas Pharma US Inc. said it would market the drug, conivaptan hydrochloride, as Vaprisol.

It will be used for euvolemic hyponatremia, a condition that can occur in hospital patients suffering from syndrome of inappropriate anti-diuretic hormone (SIADH), advanced kidney failure, hypothyroidism, cancer and chronic high blood pressure, according to the Tokyo-based company. Euvolemic hyponatremia occurs when the body retains excessive amounts of water but not sodium.

Hyponatremia is typically treated by administering diuretics, saline solution or restricting fluid intake. Vaprisol works by increasing urine output while stemming the loss of electrolytes, including sodium and potassium, the company said.

Astellas Pharma also seeks Food and Drug Administration approval for use of Vaprisol in treating hypervolemic hyponatremia in patients suffering from heart failure. Hypervolemic hyponatremia is characterized by the body's retention of both sodium and water, but more of the latter.

The FDA can approve the drug for that use if certain conditions are met, the company said.