Cornerstone Therapeutics Inc. (CRTX) announced that the U.S. Food and Drug Administration, or FDA, accepted a New Drug Application, or NDA, for CRTX 080, Cornerstone's product candidate for the treatment of hyponatremia. FDA has assigned a Prescription Drug User Fee Act goal date of October 29, 2012, the company noted.
Craig Collard, Cornerstone's chief executive officer, said, "This event marks another critical milestone in the focused execution of our strategic plan. CRTX 080 is an important addition to our hospital product portfolio. The hyponatremia market increased 86% in 2011, and we look forward to launching CRTX 080 into this rapidly expanding market."
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