New Delhi: Aurobindo Pharma on Wednesday said it has received final approval from the US health regulator for launching Donepezil Hydrochloride tablets, a central nervous system drug, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) for Donepezil Hydrochloride tablets in strengths of 5 mg and 10 mg, Aurobindo Pharma Ltd said in a statement.
“The product has a market size of approximately $2.5 billion for the twelve months ending September, 2010, according to IMS and will be launched soon,” the company said.
The Donepezil Hydrochloride Tablets are the generic equivalent of the Aricept Tablets developed by Eisai Medical Research Inc, it added.
The tablets are used for the treatment of mild, moderate and severe dementia of Alzheimer’s type and fall under the Central Nervous System (CNS) therapeutic segment, it said.
The company now has a total of 136 abbreviated new drug application (ANDA) approvals from the USFDA.
Shares of Aurobindo Pharma were being quoted at Rs178.10 apiece on the Bombay Stock Exchange in late afternoon trade on Wednesday, up 0.82% from their previous close.