Aurobindo Pharma gets U.S. FDA nod for Cephalexin tablets 

Generic drugmaker Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration to manufacture and market Cephalexin Tablets USP, 250 mg and 500 mg.

Bioequivalent and therapeutically equivalent to the reference listed drug Keflet Tablets, 250 mg and 500 mg, of Eli Lilly and Company, the product is expected to be launched by December, Aurobindo Pharma said on Tuesday.

Aurobindo has been granted Competitive Generic Therapy (CGT) designation for Cephalexin Tablets USP, 250 mg and 500 mg, and eligible for 180 days of shared generic drug exclusivity. Cephalexin Tablets USP, 250 mg and 500 mg, are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms, it said in a release.

Aurobindo Pharma now has 523 ANDA approvals (506 final approvals and 17 tentative approvals) from the U.S. FDA. The company’s shares closed 1.53% lower at Rs.1,438.55 apiece on the BSE.

Published - October 01, 2024 07:31 pm IST