The US Food and Drug Administration has approved Upsher-Smith Laboratories, Inc's abbreviated new drug application (ANDA) for memantine hydrochloride tablets in 5 mg and 10 mg strengths. Memantine hydrochloride tablets are equivalent to the branded product, Namenda, which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
"Approximately 5.3 million Americans suffer from Alzheimer's disease," said 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."
Memantine hydrochloride tablets belongs to a class of medicines called NMDA (N-methyl-D-aspartate) inhibitors. It is not known if memantine Hydrochloride Tablets are safe and effective in children.
Upsher-Smith Laboratories, Inc., founded in 1919, is a growing, fully integrated pharmaceutical company dedicated to its mission of delivering high-value, high-quality therapies and solutions which measurably improve individuals' lives.