Merck has reported that the US Food and Drug Administration (FDA) has extended the review period for Cladribine tablets, indicated for the treatment of relapsing forms of multiple sclerosis, by three months to 28 February 2011.
The extension is to allow additional time for a full review of additional information provided under the new drug application.
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The FDA granted priority review status for the tablets in July 2010 and reduced the standard review period of ten months to six months, which would have ended on 28 November 2010.
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