www.fdanews.com/articles/108946-eisai-8217-s-proposed-sedative-gets-not-approvable-letter-from-fda
Eisai’s Proposed Sedative Gets Not-Approvable Letter From FDA
July 28, 2008
Eisai Co. received a not approvable letter from the Food and Drug Administration for its proposed sedative, but the company said it would work with regulators to gain approval.
WSJ.com