Aurobindo Pharma Limited has received final US FDA approval to manufacture and market Tofacitinib Tablets in 5 mg and 10 mg strengths, the drug maker announced on June 4. The product is bioequivalent and therapeutically equivalent to the reference listed drug Xeljanz Tablets of PF Prism C.V.
Aurobindo Pharma will manufacture the tablets at APL Healthcare Unit IV, a wholly owned subsidiary, and plans an immediate launch of the product in the US.
Tofacitinib Tablets have an estimated US market size of approximately US$ 494 million, based on IQVIA MAT sales data for the twelve months ending April 2026.
Tofacitinib is indicated for moderately to severely active rheumatoid arthritis in adults with inadequate response or intolerance to methotrexate. The drug is also indicated for active psoriatic arthritis in patients with inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs.
Tofacitinib is also indicated for moderately to severely active ulcerative colitis in patients with inadequate response or intolerance to TNF blockers.
The USFDA approval brings Aurobindo Pharma's total ANDA count to 586, including 561 final and 25 tentative approvals. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad that develops and commercializes generic and branded specialty pharmaceuticals and active pharmaceutical ingredients across more than 150 countries.
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