Forest memantine review
Executive Summary
FDA's Peripheral & Central Nervous System Drugs Advisory Committee will review Forest's NDA (21-487) for memantine for the treatment of moderate-to-severe dementia of the Alzheimer's type on Sept. 24. Forest first submitted the NDA in July 2002 but withdrew the application in September 2002 because of deficiencies. Forest resubmitted the NDA on Dec. 19, 2002 with additional data (1"The Pink Sheet" April 28, 2003, p. 33). The meeting will be held at the Holiday Inn in Bethesda, Md. beginning at 8 a.m. [To 2watch a webcast or video of this meeting, go to FDAAdvisoryCommittee.com]...