FDA approves Namenda XR

NEW YORK The Food and Drug Administration has approved a drug made by Forest Labs and Germany-based Merz Pharmaceuticals for treating dementia, Forest said.

The FDA approved Namenda XR (memantine hydrochloride) as a treatment for moderate to severe dementia of the Alzheimer’s type. The drug is a 28 mg, once-daily, extended-release formulation of Namenda, which was approved in 2003. Forest obtained the right to develop and market Namenda in the United States under a licensing agreement with Merz.

Namenda had sales of $1.1 billion during the 2010 fiscal year, which ended March 31, according to an annual Securities and Exchange Commission filing by Forest.

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