Namzaric FDA Approval History
FDA Approved: Yes (First approved December 23, 2014)
Brand name: Namzaric
Generic name: donepezil and memantine
Company: Allergan plc
Treatment for: Alzheimer's Disease
Namzaric (memantine hydrochloride extended-release and donepezil hydrochloride) is an NMDA receptor antagonist and acetylcholinesterase inhibitor fixed-dose combination for the treatment of moderate to severe Alzheimer’s disease.
Alzheimer's disease is a form of dementia. It is a progressive, neurodegenerative disease characterized by loss of cognitive function such as memory and language.
Both drugs contained in Namzaric are already FDA approved and available as single ingredient products - extended-release memantine as Namenda XR, and donepezil as Aricept.
Namzaric is a once-daily oral capsule, which may be swallowed whole, or opened and sprinkled on food for patients who have trouble swallowing. It is available in two dosage strengths: 28 mg/10 mg (memantine extended release/donepezil), and 14 mg/10mg for patients with severe renal impairment.
Common side effects include headache, diarrhea, and dizziness.
Development timeline for Namzaric
Further information
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