The US Food & Drug Administration (US FDA) has granted its final approval to Aurobindo Pharma Limited for manufacturing and marketing memantine hydrochloride tablets in strength of 5 mg and 10 mg. This approval is an extension of tentative approval received on 24 March 2014. The company said it is ready for launch of the product.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Namenda tablets of Forest Laboratories Inc.
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.
