Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cephalexin tablets.
The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Keflet Tablets, of Eli Lilly and Company.
Hyderabad-based Aurobindo Pharma was granted Competitive Generic Therapy (CGT) designation for Cephalexin tablets and is eligible for 180 days of shared generic drug exclusivity.
The product is expected to be launched in Q3FY25. Cephalexin tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms.
Aurobindo Pharma now has 523 ANDA approvals (506 final approvals and 17 tentative approvals) from USFDA, according to a release.