Aurobindo Pharma has obtained the ultimate approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Deflazacort Tablets 6 mg, 18 mg, 30 mg, and 36 mg.
Bioequivalent and therapeutically equal to the reference listed drug Emflaza tablets 6 mg, 18 mg, 30 mg and 36 mg of PTC Therapeutics Inc., the product is indicated for the therapy of Duchenne muscular dystrophy (DMD). Aurobindo Pharma plans to launch the product in February.
According to PTC Therapeutics Inc., the estimated market dimension of the accepted product for the three months ended September 2023 was $67 million, Aurobindo stated on Monday. With the newest approval, the Hyderabad-based drugmaker stated it had 502 ANDA approvals (482 remaining approvals and 20 tentative approvals) from the U.S. FDA.
