Tysabri PDUFA date extended by FDA : Tysabri (Antegren or Natalizumab) - This Is MS Multiple Sclerosis Community: Knowledge & Support

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Tysabri PDUFA date extended by FDA

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squiffy2

Post subject: Tysabri PDUFA date extended by FDA

Posted: Thu Oct 20, 2011 6:06 am

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Joined: Wed Oct 14, 2009 3:00 pm
Posts: 1711

Biogen Idec and Elan Corporation, plc 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(R) (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 More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905

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Board index » Treatments » Tysabri (Antegren or Natalizumab)

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