FDA unexpectedly rejects Schering anesthesia drug

By Ransdell Pierson

NEW YORK (Reuters) - Schering-Plough Corp said (SGP.N) on Friday U.S. regulators had rejected Bridion, its drug to reverse the effects of anesthesia that had been heralded as a breakthrough product by analysts and was unanimously recommended by a federal advisory panel.

Schering-Plough shares fell 3 percent.

The U.S. Food and Drug Administration issued a "not-approvable" letter for the injectable medicine, also known as sugammadex. The agency cited concerns about "hypersensitivity/allergic reactions" to the drug but raised no concerns about its effectiveness.

Bridion was considered one of the most important products from Schering-Plough's $14.5 billion purchase last November of Organon Biosciences. Some analysts estimated it could generate annual sales of up to $1 billion if approved in the United States.

"We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March of this year," said Thomas Koestler, Schering-Plough's research chief.

The company said it will continue to press for U.S. approval of the drug and is attempting to address safety issues with the

FDA.

Bridion was approved by the European Commission on Tuesday, after a favorable recommendation by its own advisory panel.