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Surprise Move: FDA Rejects Awaited Drug

Government regulators dealt a major setback to Schering-Plough Corp., rejecting a extremely anticipated do drugs designed to help patients recover from anesthesia. (AP Photo/Mel Evans)

The Food and Drug Administration notified the company Thursday that it will not approve its drug sugammadex, due to concerns close to allergic reactions seen in some patients, according to a company statement.

Schering aforesaid in a statement issued Friday it was “surprised and foiled” by the decision only would “work with the agency to address the issues.”

Schering’s shares fell on the tidings, losing $1.13, or 5.4 percent, to $19.95 Friday morning.

The rejection letter was unexpected because a panel of outside FDA advisers had unanimously voted in favour of the medication before this yr. The FDA is non required to follow the group’s advice, though it usually does.

And on Tuesday, European Union regulators vindicated the injectable drug, which is designed to reverse the effects of anesthesia in patients after surgery. The drug will be marketed in Europe under the name Bridion, though a

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