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Merck KGaA refiles oral Multiple Sclerosis drug Cladribine

PostPosted: Tue Jun 08, 2010 10:13 pm

German pharmaceutical and chemicals company Merck KGaA said Tuesday it resubmitted its application for U.S. regulatory approval of oral multiple sclerosis treatment cladribine--seven months after the Food and Drug Administration rejected its initial submission.

The FDA last November refused to file Merck's application for approval and the German group's management has since been working with the U.S. drug regulator to address the issues that led to the refusal. A Merck spokeswoman Tuesday declined to say what additional information it provided to the FDA as part of the resubmission. ... Read More - ... ageid/1629