FDA Approves Sedative-Hypnotic Agent LUSEDRA™ Injection
Eisai Corporation of North America (Headquarters: New Jersey, the United States, Chairman & CEO: Hajime Shimizu), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito), announced that the U.S. Food and Drug Administration (FDA) has approved LUSEDRA™ (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures.
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.
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 during sedation and through the recovery process.
With the approval of LUSEDRA, Eisai will be able to provide patients and healthcare professionals with a new option for sedation in adult patients undergoing diagnostic or therapeutic procedures. Eisai will remain committed to make further contributions in addressing the diversified needs of and improving benefits to patients and healthcare professionals.
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About LUSEDRA™ Injection
LUSEDRA™ (fospropofol disodium) Injection is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase enzymes in the body into propofol. LUSEDRA is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.
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.