July 28, 2008
Eisai Receives FDA Approvable Letter for Fospropofol Disodium Injection
Eisai Corporation of North America has received a not approvable letter from the FDA, which outlines a pathway to potential approval of fospropofol disodium for use by appropriately trained physicians.
Eisai's Fospropofol disodium injection has been in review at the FDA for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures.
Mary Hedley, executive vice president of Eisai, said: "We look forward to working with the FDA to help ensure that appropriately trained physicians have this new option for patients. We believe that our clinical data submitted to the FDA supports the approval of fospropofol disodium as a potential new option for sedation of patients undergoing important diagnostic or therapeutic procedures."