The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 29 October 2012.
CRTX 080 is a non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion.
CRTX 080 acts on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.
Cornerstone chief executive officer Craig Collard said CRTX 080 is an important addition to its hospital product portfolio.
"The hyponatremia market increased 86% in 2011, and we look forward to launching CRTX 080 into this rapidly expanding market," Collard added.