New Delhi, April 16, 2015 : Aurobindo PharmaBSE 4.01 % today said it has got final approval from the US Food and Drug Administration (USFDA) to make and sell its generic version of 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 USD 123 million for the twelve months ended February 2015.
Cefixime for oral suspension is indicated for treatment of adults and pediatric 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 Unit VI formulation facility in Hyderabad, India, it said.
Aurobindo Pharma shares were trading 1.60 per cent up at Rs 1,372.40 per scrip during afternoon session on the BSE. PTI
