Aurobindo Pharma receives USFDA final approval for Deflazacort Tablets

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 US$ 67 million for the three months ending September2023, 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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