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 Inc.
Aurobindo Pharma Ltd has received USFDA Approval for Cefixime for Oral Suspension USP.
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 Inc.
Cefixime for Oral Suspension is indicated for the treatment of adults and pediatric 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 US$ 123 Million for the twelve months ending February 2015 according to IMS.
Aurobindo now has 11 ANDAs (represented by 7 product classes) approved out of Unit VI formulation facility in Hyderabad, India for manufacturing Oral Cephalosporin products.
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