Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or...

Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures FDA's Not Approvable Letter Outlines Pathway to Potential Approval WOODCLIFF LAKE, N.J., July 25 /PRNewswire/ -- Eisai Corporation of North America today announced that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA), which outlines a pathway to potential approval of fospropofol disodium for use by appropriately trained physicians. 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. "We are confident that our continued discussions with FDA will lead to the timely approval of this important new therapy," said Mary Lynne Hedley, PhD,... [read full story]