Eisai sedative not approvable

John Carroll — Mon, 28 Jul 2008 11:31:13 -0400

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 | Story

FDA staffers say that Eisai sedative appears safe

Mon, 05 May 2008 06:59:54 -0400

FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in general anesthetics. Eisai gained rights to fospropofol disodium with its acquisition of Minneapolis-based MGI Pharma. And an FDA expert committee is scheduled to meet on Wednesday to consider Eisai's application for marketing approval. The sedative is designed for use during a number of procedures, including colonoscopies. Researchers say the sedative has a safer profile than existing meds.

- read the report in the Wall Street Journal