FDA to Review Tysabri Sales Resumption
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From Bloomberg News
Biogen Idec Inc. and Irish partner Elan Corp. said U.S. regulators agreed to review their application to resume sales of multiple sclerosis medicine Tysabri, a drug withdrawn in February after a patient died.
The application will be considered under the Food and Drug Administration’s priority review process for medicines that may address unmet needs, Cambridge, Mass.-based Biogen said. That means the FDA probably will decide within six months instead of the standard 10 months.
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