Forest Submits Memantine/Donepezil NDA for Alzheimer's Disease
Forest Laboratories announced that it has submitted a New Drug Application (NDA) for a fixed-dose combination (FDC) of memantine HCl extended release (ER), a receptor antagonist and donepezil HCl, reversible acetylcholinesterase inhibitor, for the treatment of moderate to severe dementia related to Alzheimer's disease.
The NDA consisted of two dosage strengths of 28mg/10mg and 14mg/10mg (both memantine extended release/donepezil) in a once-daily oral capsule for patients with severe renal impairment currently taking memantine and donepezil. The new capsules can also be opened for the contents to be sprinkled on applesauce for patients with difficulty swallowing.
Namenda XR (memantine ER) is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Aricept (donepezil; Eisai) is indicted for the mild to severe dementia of the Alzheimer's type.
For more information call (800) 678-1605 or visit FRX.com.