USFDA Clears Aurobindo Pharma's Generic Xeljanz Tablets for Arthritis, Ulcerative Colitis
New Delhi: Aurobindo Pharma Limited has announced 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.
The product 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.
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 30+ manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s robust product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and AntiAllergic, supported by a strong R&D set-up.
