Forest Laboratories Inc. Says FDA Did Not Approve Its Drug to Treat Mild Alzheimer’s
July 29, 2005
Forest Laboratories Inc. said that the U.S. Food and Drug Administration has rejected its request to approve the drug Namenda to treat mild Alzheimer’s disease.
The FDA issued a non-approvable letter in response to Forest’s supplemental new drug application for Namenda, or memantine HCI.
Forest said it plans to meet with the FDA to further discuss the non-approvable letter.
Namenda was approved by the FDA for the treatment of moderate to severe Alzheimer’s disease in October 2003.