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GENEVA, Switzerland, June 8, 2010 / PRNewswire / – Merck Serono, a division of Merck KGaA (Darmstadt, Germany), announced it has re-submitted an application for authorization on the market (New Drug Application – NDA) with the American health authorities (U.S. Food and Drug Administration – FDA) for ‘Cladribine tablets’ treatment to reduce the frequency of relapses in patients with multiple sclerosis of relapsing. In November 2009, the company had received a letter from the FDA informing the non-admissibility of his registration dossier (Refuse to File Letter).

The oral formulation of cladribine exclusively developed by Merck Serono (‘Cladribine tablets’) is an investigational drug for the treatment of patients with multiple sclerosis relapsing. Cladribine is a synthetic molecule that acts on behavior and proliferation of certain blood cells of the white line, particularly lymphocytes, which are implicated in the pathological process of multiple sclerosis.