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news.Sun Pharmaceutical has received FDA approval for its abbreviated new drug application (ANDA) to market a generic version of Forest Laboratories’ Namenda 5mg and 10mg tablets.
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Namenda is a NMDA-receptor antagonist. It works by blocking excess activity of a substance in the brain called glutamate, which may reduce the symptoms associated with Alzheimer disease. Namenda is not a cure for Alzheimer disease.
Sun was amongst the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification to the ‘703 patent. Sun’s subsidiary is eligible for 180 days generic exclusivity.
Memantine (Namenda) helps treat the symptoms associated with Alzheimer’s disease or dementia. It is not a cure for Alzheimer’s disease but offers improvement in memory, attention, reason, language, and the ability to perform simple tasks.