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Published on 9 June 2010

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Merck resubmits US application for Cladribine tablets


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.


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