Express Pharma

Aurobindo Pharma receives US FDA approval for Cefixime for oral suspension USP

119

Cefixime for oral suspension is indicated for the treatment of adults and paediatric patients six months of age or older

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market Cefixime for Oral Suspension USP, 100mg/5mL and 200mg/5mL (ANDA 204835). The product is ready for launch.

The approved ANDAs are bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Suprax Oral Suspension USP 100mg/5mL and 200mg/5mL respectively of Lupin Pharmaceuticals.

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 gonorrhea (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. Aurobindo now has 11 ANDAs (represented by seven product classes) approved out of Unit VI formulation facility in Hyderabad, India for manufacturing oral cephalosporin products.

- Advertisement -