FDA Issues Not Approvable Letter for Schering-Plough's Sugammadex
Posted on: Tuesday, 5 August 2008, 09:01 CDT
Schering-Plough has announced that the FDA has issued a not-approvable letter for sugammadex sodium injection for the reversal of muscle relaxation during general anesthesia.
Schering-Plough has acquired sugammadex in November 2007 through its acquisition of Organon BioSciences, which developed the product.
Thomas Koestler, executive vice president and president of Schering-Plough Research Institute, said: "We remain committed to bringing this important medical advance to those who are waiting for it in the US, and plan to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions."
Source: Datamonitor
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