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As of Nov 15, 2026, ANDA 216878 (Tofacitinib Citrate), held by Hikma, was first approved by FDA on Sep 25, 2023, with 0 approved supplements and 0 published complete response letters.
First approved: Sep 25, 2023
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Tofacitinib is a Janus kinase (JAK) inhibitor. Tofacitinib oral solution is indicated for the treatment of pediatric patients 2 years of age and older with:
Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use:
Use of tofacitinib oral solution for PsA or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended ( 1.2, 1.4 ) 1.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
