Eisai anesthetic approved by FDA

The US subsidiary of Japanese drugmaker Eisai says that the Food and Drug Administration has approved its Lusedra (fospropofol disodium) injection, an intravenous sedative-hypnotic agent for monitored anesthesia care sedation in adult patients undergoing diagnostic or therapeutic procedures.

The FDA has recommended that Lusedra be classified as a controlled substance and a final scheduling decision is expected from the Drug Enforcement Administration after publishing a proposed rule in the Federal Register and allowing for public comment.

In May, the FDA Advisory Committee on Anesthetic and Life Support Drugs voted six to three in favor (with one abstention) of approval of Lusedra. The committee recommended use of the drug only by health care providers who are appropriately trained.