FDA rejects Schering-Plough's Bridion

Schering-Plough's stock fell on the surprising news that the FDA rejected Bridion (sugammadex), a treatment to reverse muscle relaxation during general anesthesia. The FDA expressed concern over allergic reactions observed in some patients. However, an outside expert panel recommended the drug, and the EU also approved it earlier this week.

"We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March of this year," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "We remain committed to bringing this important medical advance to those who are waiting for it in the United States, and plan to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions."

- check out this release [1] for more

Related Articles:
EU approves Shering-Plough's Bridion [2]
Schering-Plough wins an EC approval [3]
Organon touts late-stage data for sugammadex [4]