After reviewing data on the safety and efficacy of the medication, the committee unanimously recommended approval of the company’s application for marketing. The FDA is not bound by the committee’s recommendations; however, they usually are considered carefully before a final decision on approval is made.
Robert Spiegel, chief medical officer and senior vice president, Schering-Plough Research Institute, said: “Sugammadex has the potential to transform the practice of anesthesia through improved management of muscle relaxation in the millions of surgeries where these agents are used.”