Pharma major Lupin today said it has received final approval from the US drug regulator to market generic Aricept tablets used for the treatment of dementia.
The company’s US subsidiary, Lupin Pharmaceuticals, would commence promoting the product shortly in the US, the company said in a statement.
“...it has received final approval for its Donepezil Hydrochloride Tablets, 23 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eisai Inc’s Aricept tablets,” it added.
Lupin’s Donepezil Hydrochloride Tablets are the AB rated generic equivalent of Eisai Inc’s Aricept tablets and is indicated for the treatment of dementia of the Alzheimer’s type.
Aricept had US sales of $52.3 million (IMS MAT June 2015), it added.