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Clinical Trials Advisor
Sept. 27, 2012 | Vol. 17 No. 19
Trial Hiccups: FDA Panel Nixes Two Indications for Low-Sodium Drug
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8–0 against recommending approval of Cornerstone Therapeutics’ lixivaptan to treat hypervolemic hyponatremia associated with heart failure, citing poor trial results and dissatisfaction with use of a surrogate endpoint.
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