Zydus Cadila’s dementia drug gets US FDA nod

The drug will be manufactured at the group’s formulations manufacturing facility at Moraiya in Ahmedabad

Zydus Cadila has received a final nod from the US health regulator to market Donepezil Hydrochloride tablets used for the treatment of dementia of the Alzheimer’s type in the US market.

The company has received final approval from the United States Food and Drug Administration (US FDA) to market Donepezil Hydrochloride tablets in the strength of 23 mg, Zydus Cadila said in a statement.

The drug will be manufactured at the group’s formulations manufacturing facility at Moraiya in Ahmedabad, Zydus Cadila said.

The tablets are indicated for the treatment of dementia of Alzheimer’s disease, it added.

The group now has more than 140 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process, Zydus Cadila said.