Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Entacapone Tablets USP, 200mg (ANDA 203437). The product will be launched soon. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets 200mg of Orion Corporation.
Entacapone Tablets are used in the treatment of Parkinson's disease and has an estimated market size of US$59 Million for the twelve months ending April 2015 according to IMS. This is the 39th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-betalactam products.
