Aurobindo Pharma gets nod for Donepezil HCL Tablets
Hyderabad-based Aurobindo Pharma has informed that it has received the tentative approval for Donepezil Hydrochloride Tablets 5mg and 10mg from the US Food and Drug Administration (USFDA).
Donepezil Hydrocholoride Tablet 5mg and 10 mg is the generic equivalent to Aricept Tablets 5mg and 10mg of Eisai Medical Research Inc.
The drug is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type and falls under the Central Nervous System (CNS) therapeutic segment. The product has a market size of approximately US$ 1.9 billion for the twelve months ending Dec 2008 according to Newport.
With latest approval, Aurobindo now has a total of 99 ANDA approvals (70 final approval and 29 tentative approvals) from USFDA.






