Eisai’s Aquavan “not approvable”

Executive Summary

Eisai receives a "not approvable" action letter for its sedative fospropofol, the firm says July 25. An FDA advisory committee recommended approval of fospropofol for patients undergoing diagnostic or therapeutic procedures in May, but suggested limiting it to administration by trained anesthesiologists, thereby obviating any marketing advantage over its active moiety, propofol (1"The Pink Sheet," May 12, 2008, p. 13). The sponsor had hoped that the prodrug would have a sufficiently distinct safety profile to allow for general administration