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Merck KGaA announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for
Cladribine Tablets as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).
The company received a refuse to file letter from the FDA for
the Cladribine Tablets NDA in November 2009.
Regulatory filings for Cladribine Tablets are currently under review in a number of other locations including the European Union.