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news.Lupin has said that its US subsidiary, Lupin Pharmaceuticals has received FDA's tentative approval for the Abbreviated New Drug Application (ANDA) for its Memantine Hydrocloride tablets, 5mg and 10mg.
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Lupin’s Memantine HCL tablets are AB-rated to Namenda tablets, indicated for the treatment of modrate to severe dementia of alzheimer’s type.
Vinita Gupta, group president and CEO of Lupin Pharmaceuticals, said: “We are pleased to receive this tentative approval and look forward to bringing Memantine HCL tablets to the US market as an affordable generic alternative post patent expiry.”
Memantine Hydrochloride is an orally active NMDA receptor antagonist. The chemical name for Memantine Hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride.