Namzaric FDA Approval History
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.
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
|Dec 24, 2014||Approval Actavis and Adamas Announce FDA Approval of Namzaric (memantine/donepezil) for Alzheimer's Disease|
|Mar 4, 2014||Forest Submits NDA for Memantine ER and Donepezil Fixed-Dose Combination for Alzheimer’s Disease|
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