Cornerstone Therapeutics Inc. (CRTX) announced the Cardiovascular and Renal Drugs Advisory Committee or CRDAC of the U.S. Food and Drug Administration or FDA recommended against the approval of the Company's New Drug Application or NDA for lixivaptan (CRTX 080) for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone or SIADH, respectively.
In March 2012, Cornerstone announced the FDA's acceptance of the Company's NDA for lixivaptan. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29, 2012. The FDA takes the advisory committee's advice into consideration as part of its review of the NDA but is not bound by the committee's recommendations.
"Cornerstone is committed to continuing to work with the FDA throughout the approval process building upon meeting our primary endpoint in each pivotal Phase 3 trial," said Craig A. Collard, Cornerstone's Chief Executive Officer.
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