FDA extends priority review of oral MS drug Cladribine
FDA extends priority review of oral MS drug Cladribine
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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