Allergan and Adamas announced that the Food and Drug Administration (FDA) has approved an expanded indication for Namzaric (memantine HCl, donepezil HCl) extended-release capsules, allowing patients with moderate to severe Alzheimer’s disease who are currently stabilized on donepezil HCl (Aricept) 10mg to start directly with Namzaric. 

Namzaric combines memantine HCl, an NMDA receptor antagonist, and donepezil HCl, an acetylcholinesterase inhibitor (AChEI). Memantine HCl is postulated to exert its effect throughits action as a low to moderate affinity uncompetitive (open channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels. Donepezil is presumed to exert its therapeutic effect by enhancing cholinergic function by increasing the concentration of acetylcholine in the central nervous system through reversible inhibition of its hydrolysis by acetylcholinesterase. 

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Following the expanded indication approval, Namzaric will be available in two new dosage strengths: 7mg/10mg and 21mg/10mg capsules in 30-count bottles. Namzaric is already available as 14mg/10mg and 28mg/10mg strength capsules in 30- and 90-count bottles. The new strengths are expected to be available in September.

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