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FDA extends cladribine review

November 30, 2010 12:13 AM UTC

FDA extended the PDUFA date for cladribine tablets from Merck KGaA (Xetra:MRK) by three months to Feb. 28, 2011, from Nov. 28. The NDA is under Priority Review to treat relapsing forms of multiple sclerosis (MS). Merck resubmitted the application in June after FDA refused to file the application last year. According to Merck, FDA said it needs time for a full review of additional information. ...