US priority review status for oral MS drug Cladribine

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US priority review status for oral MS drug Cladribine

Postby MSUK » Tue Jul 27, 2010 11:41 pm


German pharmaceutical and chemicals company Merck KGaA has announced that the U.S. Food and Drug Administration accepted a new drug application for its oral multiple sclerosis treatment Cladribine with a priority review designation, after Merck's initial submission was rejected last fall.

Priority review status is applied to drugs that have the potential to provide significant advances in treatment and means the FDA will complete its review in six months rather than the usual 10. Merck expects a decision in the fourth quarter....Read More - ... ageid/1629
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