Aurobindo Pharma has received the final 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 equivalent 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 treatment of Duchenne muscular dystrophy (DMD). Aurobindo Pharma plans to launch the product in February.
According to PTC Therapeutics Inc., the estimated market size of the approved product for the three months ended September 2023 was $67 million, Aurobindo said on Monday. With the latest approval, the Hyderabad-based drugmaker said it had 502 ANDA approvals (482 final approvals and 20 tentative approvals) from the U.S. FDA.
