Eisai sedative not approvable

A sedative Eisai gained through its acquisition of MGI Pharma has been hit with a ‘not approvable' letter from the FDA. But the pharma company says it strongly believes that further talks with the agency will lead to an approval for fospropofol disodium, which was endorsed by an FDA expert committee, with the caveat that it would like to see more data on the drug's potential impact on the obese and elderly. Release [1] | Story [2]