US FDA grants tentative approval for Sun's generic Aricept

Mumbai: Sun Pharmaceutical  today said that ther US FDA has granted a tentative approval for an abbreviated new drug application to market its generic version of Aricept, donepezil hydrochloride tablets, used in the treatment of dementia.

These generic donepezil hydrochloride tablets, equivalent to Eisai's aricept tablets, include two strengths: 5 mg and 10 mg, the annual sales of which  in the US is approximately $2.5 billion.

Donepezil hydrochloride tablets are indicated in the treatment of dementia of the Alzheimer's type.

Efficiency has been demonstrated in patients with mild, moderate and severe Alzheimer's disease, Sun said in a statement.

Aricept is a registered trademark of Japan's Eisai co. Ltd.