Aurobindo Pharma Gets USFDA approval for Parkinson’s drug

Aurobindo Pharma, the Hydrabad based Pharmaceutical company has received the approval from USFDA to produce and market market Entacapone Tablets USP, 200mg (ANDA 203437).

 

The approved product is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets 200mg of Orion Corporation. The tablet Entacapone functions as a catechol-O-methyl transferase (COMT) inhibitor and is used in the treatment of Parkinson's disease. This is the 39th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-betalactam products