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Monday, November 30, 2009

Oral Cladribine's approval - denied by FDA

EMD Serono Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application

  • Press Release
  • Source: EMD Serono, Inc. - On 9:06 am EST, Monday November 30, 2009

ROCKLAND, Mass., Nov. 30 /PRNewswire/ -- EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS).

"The company will work closely with the FDA to fully understand FDA's concerns and define a path forward for a successful resubmission of this application at the earliest point in time," said Elmar Schnee, Member of the Executive Board Merck KGaA and Head of Pharmaceuticals. "We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options."

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