Aurobindo Pharma today said it has got final approval from the US Food and Drug Administration (USFDA) to make and sell a generic version of the oral suspension of antibiotic Cefixime.
The approval by the USFDA is for strengths of 100 mg/5 ml and 200 mg/5 ml and the product is ready for launch, Aurobindo Pharma said in a statement.
The approved solutions are bio-equivalent and therapeutically equivalent to the reference listed drug product Suprax Oral Suspension USP 100 mg/5 mL and 200 mg/5 mL, respectively of Lupin Pharmaceuticals Inc, it added.
Citing IMS data, the company said the product has an estimated market size of $123 million for the 12 months ended February 2015.
Cefixime for oral suspension is indicated for the treatment of adults and paediatric patients of six months of age or older, in urinary tract infections, acute exacerbations of chronic bronchitis, uncomplicated gonorrhea, pharyngitis and tonsillitis, among others, it added.
Aurobindo now has 11 abbreviated new drug applications approved out of the Unit VI formulation facility in Hyderabad, India, it said.
Aurobindo Pharma shares were trading up 1.60 per cent at Rs 1,372.40 per scrip in the afternoon session on the BSE.