“The latest setback came for the drug sugammadex, which is designed to reverse the effects of muscle relaxants given under general anesthesia during surgery.”
“But in early August, the FDA decided to reject Schering-Plough Corp. 's sugammadex, a drug that helps patients recover from anesthesia, even though the panel decided unanimously to approve it.”
“Thomas Koestler, said in a statement that the company was "surprised and disappointed" by the FDA's "non-approvable letter," which forestalls approval of sugammadex.”
“The European Union's drug regulator had approved sugammadex earlier in the week; it will be marketed under the brand Bridion.”
“Schering said it plans to meet with the FDA to discuss its concerns, and "to find a path forward with sugammadex.”
“The list includes the cholesterol drug Cordaptive from Merck, the heart medication Kynapid from Cardiome Pharma and the anesthesia-complication drug sugammadex from Schering-Plough.”
“The treatment, sugammadex, had received unanimous support from an FDA advisory panel in March.”
“Cervarix and Arcoxia are on the market in Europe, while sugammadex has been recommended for approval there.”
“The FDA has delayed approval of Glaxo's cancer vaccine, Cervarix, and Schering-Plough's sugammadex, a drug designed to be used after surgeries to quickly undo the effects of muscle relaxants, and rejected Merck's pain medicine Arcoxia.”
“The drug, sugammadex, would be used to reverse the effects of muscle-paralyzing drugs used in some surgeries.”
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