Aurobindo Pharma Gets Final US FDA Nod for Tofacitinib Tablets

Aurobindo Pharma announced it has received final approval from the US FDA for Tofacitinib Tablets in 5 mg and 10 mg strengths. These tablets are bioequivalent to Xeljanz Tablets. The product will be manufactured at its subsidiary APL Healthcare Unit IV and launched immediately. The US market for Tofacitinib Tablets was approximately $494 million in April 2026. This approval brings Aurobindo's total US FDA ANDA approvals to 586. The drug is indicated for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.