Aurobindo Pharma Limited announced that it 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 USD 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.
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- Aurobindo Pharma Limited Receives USFDA Approval for Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg