Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Deflazacort Tablets, 6 mg, 18 mg, 30 mg and 36 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), EMFLAZA tablets 6 mg, 18 mg, 30 mg and 36 mg of PTC Therapeutics Inc. The product will be launched in February 2024.
The approved product has an estimated market size of $67 million for the three months ending September 2023, according to PTC Therapeutics Inc. Aurobindo now has a total of 502 ANDA approvals (482 Final approvals and 20 tentative approvals) from USFDA. Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
