Aurobindo Pharma receives US FDA nod for antibiotic Cefixime oral suspension

The US Food & Drug Administration (US FDA) has granted final approvals to Aurobindo Pharma Limited for manufacturing and marketing cefixime for oral suspension USP, 100mg/5mL and 200mg/5mL. The approved ANDAs are bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Suprax oral suspension USP 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 $ 123 million for the twelve months ending February 2015, according to IMS.