FDA Approves Dementia Drug Namenda XR

Forest Laboratories Inc. and Merz Pharmaceuticals GmbH June 21 announced that the Food and Drug Administration has approved Namenda XR (memantine hydrochloride) for the treatment of moderate to severe dementia of the Alzheimer’s type.

Namenda XR is a 28 mg once-daily extended-release formulation of Namenda, the companies said. Namenda, a twice daily immediate release formulation, was approved by FDA in October 2003 for the treatment of Alzheimer’s disease (1 PLIR 1136, 10/24/03).

The companies said they are determining the appropriate commercialization strategy and market timing for the drug.