June 03, 2008
Schering-Plough said a committee of the European Medicines Agency has endorsed its drug sugammadex to reverse the effects of two muscle relaxants widely used in surgery. The committee's recommendations are typically adopted by European Union nations. Schering-Plough is still awaiting an FDA decision on sugammadex, which would be marketed in the US under the brand name Bridion. In a March, a FDA panel of experts unanimously voted in favor of approving the injectable drug. The agency is scheduled to make a final decision by early August.
AstraZeneca has submitted a supplemental new drug application to the FDA for Nexium IV for injection to seek approval for use in patients with peptic ulcer bleeding following therapeutic endoscopy.