Drug firm Sun Pharmaceutical Industries today said it has received a tentative approval from US health regulator to market generic donepezil hydrochloride tablets used for treating Alzheimer's disease in the American market.
The tentative approval has been given by United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) to market donepezil hydrochloride tablets in the strengths of 5 mg and 10 mg, the company said in a statement.
"Annual sale in US for these strengths is approximately $2.5 billion," Sun Pharma added.
Donepezil hydrochloride tablets are generic version of drug major Eisai's Aricept tablets and are used in the treatment of Alzheimer's disease.
Shares of Sun Pharma today closed at Rs 448.75 on the Bombay Stock Exchange (BSE), down 0.14 per cent from its previous close.