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news.Eisai Corporation of North America has announced that the FDA has approved Lusedra injection, an intravenous sedative-hypnotic agent for monitored anesthesia care sedation in adult patients undergoing diagnostic or therapeutic procedures.
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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.
The FDA has also recommended that Lusedra be classified as a controlled substance. A final scheduling decision is expected from the US Drug Enforcement Administration 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.
Cynthia Schwalm, president of Eisai, said: “We are pleased with the FDA’s decision to approve Lusedra, as it provides a new option for monitored anesthesia care sedation in adult patients. With the approval of Lusedra, Eisai continues to fulfill its human health care mission to address the unmet needs of patients.”