Aurobindo to launch Cefixime oral suspension in the US, gets final approval

Aurobindo Pharma Limited announced on Wednesday that the company has received final approvals from the US Food and Drug Administration (US FDA) to manufacture and market Cefixime for Oral Suspension of different doses. The product is ready for launch, the company said.

The approved abbreviated new drug application (ANDA) is a bioequivalent and therapeutically equivalent to the reference listed drug product Suprax oral suspension of Lupin Pharmaceuticals Inc., according to the company. The product has an estimated market size of $ 123 million for the twelve months ending February 2015, it said quoting the IMS data.

Cefixime is indicated for treatment of a variety of infections including urinary tract infection both in adults and paediatric patients of six months of age or older. Aurobindo now has 11 ANDAs represented by 7 product classes approved out of unit 6 formulation facility in Hyderabad for manufacturing of oral Cephalosporin products, according to the press release.