sugammadex

The latest setback came for the drug sugammadex, which is designed to reverse the effects of muscle relaxants given under general anesthesia during surgery.

Schering-Plough Postsurgery Drug Rejected by FDA 2008

Schering said it plans to meet with the FDA to discuss its concerns, and "to find a path forward with sugammadex."

Schering-Plough Postsurgery Drug Rejected by FDA 2008

Cervarix and Arcoxia are on the market in Europe, while sugammadex has been recommended for approval there.

Drug Makers Say FDA Safety Focus 2008

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.

Drug Makers Say FDA Safety Focus 2008

The treatment, sugammadex, had received unanimous support from an FDA advisory panel in March.

Hardly Working 2008

The European Union's drug regulator had approved sugammadex earlier in the week; it will be marketed under the brand Bridion.

Schering-Plough Postsurgery Drug Rejected by FDA 2008

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.

FDA Rejects Advisers, 2008

The treatment, sugammadex, had received unanimous support from an FDA advisory panel in March.

Grinding Gears 2008

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.

Schering-Plough Postsurgery Drug Rejected by FDA 2008

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.

Drugs With Market Potential 2008