Aurobindo Pharma, a mid-size pharmaceutical company, today announced that the company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Memantine Hydrochloride tablets, 5mg and 10mg.
This approval is an extension of tentative approval received on Mar 24, 2014. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product 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.
According to IMS, the approved product has an estimated market size of USD 1.23 billion for the twelve months ending August 2015.
Shares of the company gained Rs 0.65, or 0.08%, to trade at Rs 812 at the BSE (12.30 p.m., Wednesday).