FDA Denies Approval of Lixivaptan, Citing Need for More Information

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Lixivaptan will not be approved until the Food and Drug Administration is able to see more data in regards to the drug.  Cornerstone Therapeutics is the company behind the drug, which is meant to treat a condition known as hyponatremia.  This condition is what happens when a person’s blood does not have enough sodium.  An Advisory Committee at first recommended against approval, and the FDA has apparently concurred, saying that there needs to be more information about the drug before approval is allowed.  In addition, the advisory panel came to the unanimous conclusion that the drug should in particular not be used if the hyponatremia condition stems from heart failure.

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