Generic drugmnaker Aurobindo Pharma has received U.S. Food and Drug Administration (U.S. FDA) final approval to manufacture and market Tofacitinib tablets, 5 mg and 10 mg.The product is bioequivalent and therapeutically equivalent to reference listed drug Xeljanz Tablets, 5 mg and 10 mg, of PF Prism C.V. It will be manufactured at subsidiary APL Healthcare’s Unit IV and launched immediately, Aurobindo Pharma said on Thursday.Tofacitinib tablets, 5 mg and 10 mg, have an estimated market size of around $494 million in the U.S., the company said citing IQVIA MAT data for the twelve months ending April 2026. They are indicated for treatment of adults with moderately to severely active rheumatoid arthritis; active psoriatic arthritis; and moderately to severely active ulcerative colitis (UC). Published - June 04, 2026 10:12 pm IST
Aurobindo Pharma’s generic of rheumatoid arthritis drug secures U.S. FDA nod
Generic drugmnaker Aurobindo Pharma has received U.S. Food and Drug Administration (U.S. FDA) final approval to manufacture and market Tofacitinib tablets, 5 mg and 10 mg.
130 words~1 min read
