Aurobindo Pharma receives US FDA Approval for Alzheimer’s drug

The approved product has an estimated market size of $1.23 billion according to IMS

Aurobindo Pharma has received the final approval from the US Food & Drug Administration (US FDA) to manufacture and market memantine hydrochloride tablets, 5mg and 10mg (ANDA 203175). This approval is an extension of tentative approval received on 24 March 2014. The product is ready for launch.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) NAMENDA 5mg and 10mg of Forest Laboratories.

Memantine hydrochloride tablets are used for the treatment of moderate to severe dementia of the Alzheimer’s type. The approved product has an estimated market size of $1.23 billion for the twelve months ending August 2015 according to IMS.

Aurobindo now has a total of 215 ANDA approvals (188 final approvals including 10 from Aurolife Pharma and 27 tentative approvals) from US FDA.