TWi Pharmaceuticals, Inc. today announced that it has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.'s Aricept® 23mg. Aricept® 23mg is used to treat Alzheimer's disease patients.
TWi Pharmaceuticals is preparing to launch the product in the US via its fully owned subsidiary, TWi Pharmaceuticals USA, at the earliest time possible.
According to IMS Health, US sales of Aricept® 23mg were approximately $78 million for the 12 months ended June 2014.
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