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Namzaric 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 History and FDA Approval Process for Namzaric

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

Further information

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