US FDA rejects Schering-Plough's post-surgery drug Sugammadex

Mumbai: The US Food and Drug Administration (FDA) has rejected Schering-Plough Corporatin's  new anesthesia product Sugammadex, saying the drug designed to undo the affects of muscle relaxants after surgeries, was  non-approvable.

FDA has issued a ''non-approvable" letter for the product, citing concerns that the drug might cause allergic reactions in some users, Schering-Plough said in a statement.

The rejection followed human tests of the drug, in which one patient suffered a severe allergic reaction.

The drug, also called Bridion, is injected into the body, was designed as a safer, faster alternative to older drugs used to reverse anesthesia.

An FDA advisory panel had recommended approval of the drug in March. The drug also got approval from the European regulators earlier this week.

Schering-Plough said the treatment had received unanimous support from an FDA advisory panel and the current decision has come as a surprise.

FDA, however, is not bound to the recommendations of its committees although it generally follows them.

The company said it plans to work with the FDA to ``address the issues, which are primarily related to hypersensitivity/allergic reactions,'' and try to eventually bring the product to market. 

Schering-Plough, based in Kenilworth, New Jersey, bought the rights to Sugammadex through its acquisition of Organon Biosciences.