Forest Laboratories reported that its New Drug Application (NDA) for memantine, the first of a new class of Alzheimer's agents, was accepted for filing by the U.S. Food and Drug Administration (FDA). Under existing FDA procedures, the company should be receiving an initial action letter from the FDA by the end of 2003.
Howard Solomon, chairman and chief executive officer of Forest said, "Although the acceptance of the filing of the NDA does not indicate FDA approval, we believe that the data we have provided demonstrate that memantine provides a significant therapeutic benefit to patients with this devastating disorder."