FDA Panel Say No to Cornerstone Therapeutics Inc.'s Lixavaptan
Published: Sep 14, 2012
Cornerstone Therapeutics Inc failed to win a U.S. advisory panel's support on Thursday for a drug that treats low sodium levels in the blood. The panel of outside advisers to the Food and Drug Administration voted five to three to recommend rejection of lixivaptan for treating low sodium due to a condition that causes the body to have excess water. They also unanimously voted against using the drug to treat low sodium in heart failure patients. The FDA usually follows panel recommendations, but it is not required to. A final decision is expected by October 29. Shares of the company were halted pending the panel meeting.