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Biogen Idec, Inc. (Massachusetts) (BIIB) and Elan Corporation PLC (ELN) Receive Notification of PDUFA Date Extension



10/20/2011 11:13:49 AM

WESTON, Mass. & DUBLIN--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab). The sBLA was submitted in December 2010 to update the Prescribing Information for TYSABRI to include anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML) in the TYSABRI-treated population. The 3 month extension is a standard extension period.

Read at BioSpace.com


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