Sun Pharma Announces USFDA Tentative Approval for Generic Aricept

Mumbai : Sun Pharmaceutical Industries Ltd announced that USFDA has granted a tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Aricept, donepezil hydrochloride tablets.

These generic donepezil hydrochloride tablets, equivalent to Eisai’s Aricept tablets, include two strengths: 5 mg and 10 mg. Annual sale in US for these strengths 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.

Aricept is a registered trademark of Eisai co. Ltd.