Upsher-Smith gains approval for Namenda generic

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MAPLE GROVE, Minn. — Upsher-Smith Laboratories Inc. has received approval from the Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for memantine hydrochloride tablets, a treatment for Alzheimer’s disease, in strengths of 5 mg and 10 mg.

Upsher-Smith said Monday that its product is a generic version of Namenda from Forest Laboratories, now part of Actavis.

Part of a class of medicines known as NMDA inhibitors, memantine hydrochloride tablets are a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer’s disease.

“Approximately 5.3 million Americans suffer from Alzheimer’s disease,” stated Rusty Field, president of Upsher-Smith. “With the FDA approval of Upsher-Smith’s generic memantine hydrochloride tablets, it is our hope to increase access to a cost-effective alternative to Namenda for those patients experiencing moderate to severe dementia of the Alzheimer’s type.”


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