Biogen Idec en Elan ontvangen melding van verlenging PDUFA datum

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Biogen Idec en Elan ontvangen melding van verlenging PDUFA datum

//health-fitness.news-articles.net/content/2011/ .. ntvangen-melding-van-verlenging-pdufa-datum.html

Published in Health and Fitness on Thursday, October 20th 2011 at 11:12 GMT by Market Wire
^{🞛 This publication is a summary or evaluation of another publication}

WESTON, Mass. & DUBLIN--([ BUSINESS WIRE ])--Biogen Idec (NASDAQ: BIIB) en Elan Corporation, plc (NYSE: ELN) maken bekend dat de Amerikaanse Food and Drug Administration (FDA) de oorspronkelijke PDUFA datum voor de beoordeling van de supplementaire Biologics License Application (sBLA) voor Tysabri (natalizumab) heeft verlengd. De sBLA werd in december 2010 ingediend om de samenvatting van productkenmerken van Tysabri uit te breiden met de status als antilichaam voor anti-JC-virus als factor bij de stratificatie van het risico op progressieve multifocale leuko-encefalopathie (PML) in de met Tysabri behandelde populatie. De verlenging met drie maanden is de gebruikelijke periode.

Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal welke als enige juridische geldigheid beoogt.

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