An FDA committee has unanimously recommended Schering-Plough's sugammadex for approval. The drug, which is being developed to reverse the effects of anesthesia used during surgery, allows doctors to reverse the depth of a patient's muscle relaxation within minutes. The FDA usually [1] follows the committee's recommendation. The drug gained priority review in January.
Schering gained sugammadex in its massive $14.4 billion buyout of Organon [2] one year ago. Sugammadex will be sold under the name Bridion if approved.
Related Articles:
FDA to give Schering program priority review. Report [3]
Organon touts late-stage data for sugammadex. Report [4]
Links:
[1] http://www.fiercepharma.com/story/does-avastin-nod-lower-approvals-bar/2008-02-25
[2] http://www.fiercebiotech.com/story/schering-plough-pays-14.4b-for-organon/2007-03-12
[3] http://www.fiercebiotech.com/story/fda-give-schering-program-priority-review/2008-01-03
[4] http://www.fiercebiotech.com/story/organon-touts-late-stage-data-for-sugammadex/2007-06-11