Aurobindo Pharma receives USFDA Approval for Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg

Aurobindo Pharma Limited 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 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.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1017.95 as compared to the previous close of Rs. 1002.00. The total number of shares traded during the day was 263489 in over 10099 trades.

The stock hit an intraday high of Rs. 1038.75 and intraday low of 1000.20. The net turnover during the day was Rs. 268997949.00.

Source : Equity Bulls

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AurobindoPharma INE406A01037 USFDA Approval DeflazacortTablets