Monday, November 30, 2009

Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application

Merck KGaA announced today that its US affiliate received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, Merck Serono’s proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS).

The details can be read here.

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