The FINANCIAL — Eisai Corporation of North America on December 14 announced that the U.S. Food and Drug Administration (FDA) has approved LUSEDRA (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.
In the approval, the FDA required that LUSEDRA be used only by persons trained in the administration of general anesthesia and that all patients should be continuously monitored by persons not involved in the conduct of the procedure.
On May 7, 2008, the FDA Advisory Committee on Anesthetic and Life Support Drugs voted 6 to 3 in favor (with one abstention) of approval of LUSEDRA for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures. The committee recommended use of LUSEDRA by healthcare providers who are appropriately trained.
"We are pleased with the FDA's decision to approve Lusedra, as it provides a new option for monitored anesthesia care (MAC) sedation in adult patients," said Cynthia Schwalm, President, Eisai Inc. "With the approval of Lusedra, Eisai continues to fulfill its human health care mission to address the unmet needs of patients."
The FDA has recommended that LUSEDRA be classified as a controlled substance. A final scheduling decision is expected from the U.S. Drug Enforcement Administration (DEA) after publishing a proposed rule in the Federal Register and allowing for public comment. Once LUSEDRA receives final scheduling designation, the label will be amended.