Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Tofacitinib Tablets, in 5 mg and 10 mg dosages. These tablets are bioequivalent and therapeutically equivalent to Xeljanz Tablets, 5 mg and 10 mg, manufactured by PF Prism C.V. The product will be manufactured at APL Healthcare Unit IV, a wholly-owned subsidiary of Aurobindo Pharma, and is slated for immediate launch. The estimated market size for Tofacitinib Tablets in the US is approximately US$ 494 million, based on IQVIA MAT data for the twelve months ending April 2026. This approval adds to Aurobindo Pharma's portfolio, bringing their total USFDA ANDA approvals to 586, comprising 561 final and 25 tentative approvals. Tofacitinib Tablets are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis, particularly those who have had an inadequate response or intolerance to existing treatments.
