FDA extends priority review of oral MS drug Cladribine

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FDA extends priority review of oral MS drug Cladribine

Post by MSUK » Fri Nov 26, 2010 2:44 am

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The U.S. drugs watchdog will take more time to decide over Merck KGaA's multiple sclerosis (MS) pill, the German company said on Friday, two months after drawing a rejection from European regulators.

The U.S. Food and Drug Administration (FDA) extended its review period for cladribine pills as a therapy for relapsing forms of (MS) by three months to Feb. 28, 2011, Merck said.

"The FDA extended the review period to provide additional time for a full review of additional information provided under the new drug application," the company added.... [Read More] - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1629
MS-UK - http://www.ms-uk.org/

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