Aurobindo Pharma Limited has recently informed exchanges that the US Food and Drug Administration (USFDA) has granted final approval to manufacture and market Cephalexin Tablets USP, 250 mg and 500 mg, which are bioequivalent and therapeutically equivalent to Eli Lilly and Company’s reference listed drug (RLD), Keflet Tablets 250 mg and 500 mg.
Cephalexin Tablets USP, 250 mg and 500 mg are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms.
The company has been granted for 180 days of shared generic drug exclusivity after receiving CGT designation. The launch is expected during Q3FY25. This brings Aurobindo’s total ANDA approvals from USFDA to 523.
