Aurobindo Pharma Ltd announced that it’s tentatively approved Abbreviated New Drug Application (ANDA) for Donepezil hydrochloride tablets 5mg and 10mg has received the final approval from the US Food and Drug Administration (US FDA).
Donepezil hydrochloride tablets 5mg and 10mg is the generic equivalent to Aricept tablets 5mg and 10mg of Eisai Medical Research Inc. Donepezil hydrochloride tablets are indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type and fall under the Central Nervous System (CNS) therapeutic segment. The product has a market size of approximately US$ 2.5 billion for the twelve months ending September 2010 according to IMS. The Hyderabad-based company will launch the products shortly.
Aurobindo now has a total of 136 ANDA approvals, including106 final approvals and 30 tentative approvals, from US FDA.