Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cephalexin Tablets USP, 250 mg and 500 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Keflet Tablets, 250 mg and 500 mg, of Eli Lilly and Company.

Aurobindo Pharma was granted Competitive Generic Therapy (CGT) designation for Cephalexin Tablets USP, 250 mg and 500 mg, and is eligible for 180 days of shared generic drug exclusivity.

The product is expected to be launched in Q3FY25.

Cephalexin Tablets USP, 250 mg and 500 mg are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms.

Aurobindo Pharma now has a total of 523 ANDA approvals (506 Final approvals and 17 tentative approvals) from USFDA.