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 US$ 2.5 bn.
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.
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