East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Tofacitinib Tablets, 5 mg and 10 mg. Aurobindo Pharma’s Tofacitinib Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Xeljanz Tablets, manufactured by PF Prism C.V.

Tofacitinib Tablets are indicated for the treatment of:

• Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
• Adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
• Adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.