Aurobindo Pharma receives final US FDA approval for Tofacitinib Tablets, 5 mg and 10 mg

Aurobindo Pharma Limited is pleased to announce that it has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Tofacitinib Tablets, 5 mg and 10 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xeljanz Tablets, 5 mg and 10 mg, of PF Prism C.V.

The product will be manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of the company and will be launched immediately.

According to IQVIA MAT data for the twelve months ending April 2026, Tofacitinib Tablets, 5 mg and 10 mg have an estimated market size of approximately US$ 494 million in the U.S.

Aurobindo Pharma now has a total of 586 ANDA approvals (561 final approvals and 25 tentative approvals) from USFDA.

Tofacitinib Tablets are indicated for: (1) the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, (2) the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs), (3) the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1462.55 as compared to the previous close of Rs. 1463.60. The total number of shares traded during the day was 77718 in over 5962 trades.

The stock hit an intraday high of Rs. 1496.15 and intraday low of 1457.65. The net turnover during the day was Rs. 115100556.00.

Source : Equity Bulls

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AurobindoPharma INE406A01037 Pharmaceuticals USFDA Approval TofacitinibTablets