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FDA extends PDUFA date on Novartis's Gilenia by three months

This article was originally published in Scrip

Executive Summary

The US FDA has pushed back the PDUFA data for Novartis's Gilenia (fingolimod) — an experimental oral multiple sclerosis drug — by three months, until 21 September 2010. The agency had previously granted the drug a six month priority review, with a decision expected by 21 June.



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