Keywords: Merck KGaA, cladribine, FDA approval delay
US FDA delays Merck KGaA’s filing on MS drug cladribine
Article | 1 December 2009
In a move that will delay the approval of German drug major Merck KGaA’s multiple sclerosis drug cladribine, the US Food and Drug Administration has issued a “refuse to file” letter on the firm’s New Drug Application for the compound as a therapy for relapsing forms of MS.
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