New Delhi: Aurobindo Pharma 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.
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.
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