Aurobindo Pharma gets tentative USFDA nod for Alzheimer drugDrug maker, Aurobindo Pharma (Q,N,C,F)* has received the tentative approval for Donepezil Hydrochloride Tablets 5 mg and 10 mg (ANDA 90-056) from the US Food & Drug Administration (USFDA).

Donepezil Hydrochloride Tablets 5 mg and 10 mg is generic equivalent of Aricept tablets 5 mg and 10 mg of Eisai Medical Research and are indicated for the treatment of mild, moderate and severe demetia of Alzheimer`s type and fall under the central nervous system (CNS) therapeutic segment. The product has a market size of approximately USD 1.90 billion for the twelve month ending Dec 2008 according to Newport.

Aurobindo now has a total of 99 ANDA approvals (70 final approvals and 29 tentative approvals) from USFDA.