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Schering-Plough's Bridion: US says no, EU says yes

This article was originally published in Scrip

Executive Summary

The US FDA has rejectedSchering-Plough's neuromuscular blockade reversal agent Bridion (sugammadex sodium injection) over safety concerns just days after the product was licensed in the EU. The FDA move is a big setback for Schering-Plough in light of an advisory panel's unanimous approval recommendation and is further fuelling industry complaints that the agency has become too conservative in its approval decisions.



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