Aurobindo Pharma Limited, a Rs. 5,775 crore plus Hyderabad-based pharma major, has received approval from the US Food and Drug Administration (FDA) to manufacture and market generic version of oral suspension of antibiotic Cefixime.
The product which received US FDA approval for concentrations--100mg/5ml and 200mg/5ml is ready for launch.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) suprax oral suspension USP 100mg/5ml and 200mg/5m respectively of Lupin Pharmaceuticals Inc.
Cefixime for oral suspension is indicated for the treatment of adults and paediatric patients six months of age or older, with infections caused by susceptible strains of the designated organisms in urinary tract infections, otitis media, acute exacerbations of chronic bronchitis, uncomplicated gonorrhoea (cervical/urethral), pharyngitis and tonsillitis.
The product has an estimated market size of USD 123 million for a year ended February 2015, according to IMS.