In fact, the panel voted unanimously to recommend that the FDA approve Bridion, Schering's drug used to reverse the effects of muscle blocks during surgery. The panel said that the drug could be used in all the situations that Schering had requested, including emergencies where patients need to be revived quickly. On the safety front, the panel recommended post-marketing studies to make sure that the minor problems seen in the clinical trials actually are minor. Overall, the results of the panel's meeting were the best Schering could have hoped for.
The FDA doesn't always follow a panel's recommendation -- think Genentech
The only question now is how well Schering will be able to market the drug. Bridion works much better than drugs made by generic-drug makers Novartis
Schering needs Bridion to succeed, not only to justify its $14 billion acquisition of the Organon BioSciences unit of Akzo Nobel
Fortunately, Schering has a well-stocked pipeline, so if Bridion doesn't live up to its potential, the drugmaker has other drugs right behind it.
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