Generic drugmaker Aurobindo Pharma has acquired closing approval from the U.S. Meals and Drug Administration to fabricate and market Cephalexin Tablets USP, 250 mg and 500 mg.
Bioequivalent and therapeutically equal to the reference listed drug Keflet Tablets, 250 mg and 500 mg, of Eli Lilly and Firm, the product is predicted to be launched by December, Aurobindo Pharma stated on Tuesday.
It has been granted Aggressive Generic Remedy (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 remedy of infections attributable to prone strains of the designated microorganisms, it stated in a launch.
Aurobindo Pharma now has 523 ANDA approvals (506 closing approvals and 17 tentative approvals) from the U.S. FDA. The corporate’s shares closed 1.53% decrease at ₹1,438.55 apiece on the BSEOM
Printed – October 01, 2024 07:55 pm IST
